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¶}ª©·|­û¡u¥ý¶i¡v½Ðºô¤Íµo¨¥µÛ­«©ó²z©Ê°Q½×·sÃĶi«×¡AµL¿×¤£²z©Êªº¥´À£¡A½Ð¦Ü¨ä¥Lª©°Ï¡A¤À¬y¬O¬°¤F¦³§Q§ë¸ê¤H·j´M

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¸g¼Ú·ùµ¹¤© new active substance ¤W¥«³\¥iªº·sÃÄ¡A¥i¦Û¥Ñ­q©wÃÄ«~°_©l»ù®æ(initial price)¡C
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B) New Active Substance (NAS): Ropeginterferon alpha 2b ³Ì²×³Q»{¥iÄÝ©ó(³Ð)·s¬¡¤Æª«½è „» ³o¦b¨ä¥L³W³¹¸Ì¦³«D±`Ácº¾ªº³¯­z¦p¦ó²Å¦XNAS

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pharmaintelligence.informa.com/resources/product-content/sitecore/shell//~/media/informa-shop-window/pharma/files/pdfs/pharma-rd-annual-review-webinar-2018-slides.pdf

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Besremi: EPAR Public Assessment Report (5/8/2019)

www.ema.europa.eu/en/medicines/human/EPAR/besremi

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1. ±q5/8/2019ªº¤½¶}§¹¾ãµû¦ô³ø§i¸Ì, ±q¤å¥óªºBackground info¥H¤Î³Ì«á­±ªº­«ÂI¦³¤G:

1-1) Besremi¨ü©t¨àÃĪº¥«³õ«OÅ@,

1-2)¨Ì·Ó³W©w, ¨â­Ó(·Ç«h)­«ÂI (page6):

A) Similarity: ¬O§_²{ªp¦³¼Ú·ù®Ö­ãfor PV¬Û¦üÃĪ«? (µª®×¬O¨S¦³, ©Ò¥HAOP/Pharmaessentia¥Ó½Ð¤HµL±q´£¥æ¤@¥÷³ø§i, »¡©ú»P±ÂÅvªºBesremi©t¨àÃĪ«¥i¯à¦³¬Û¦ü¤§³B, ¦]¬°¦b»P«Øijªº¾AÀ³¯g¦³Ãöªº±¡ªp¤U, ¨S¦³¤w±ÂÅvªº©t¨àÃIJ£«~¥i³¯­z)

B) New Active Substance (NAS): Ropeginterferon alpha 2b ³Ì²×³Q»{¥iÄÝ©ó(³Ð)·s¬¡¤Æª«½è „» ³o¦b¨ä¥L³W³¹¸Ì¦³«D±`Ácº¾ªº³¯­z¦p¦ó²Å¦XNAS

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(°Ñ¦Ò¤U­±ªþ¥ó) www.ema.europa.eu/en/documents/presentation/presentation-new-active-substance-categorisation-orphan-similarity-piotr-kozarewicz_en.pdf

Page6:

Information relating to orphan market exclusivity

ƒÞ Similarity

Pursuant to Article 8 of Regulation (EC) No. 141/2000 and Article 3 of Commission Regulation (EC) No 847/2000, the applicant did not submit a critical report addressing the possible similarity with authorised orphan medicinal products because there is no authorised orphan medicinal product for a condition related to the proposed indication.

ƒÞ Applicant¡¦s request for consideration

New active Substance status

P112: #4 Recommendation

CHMP considers that ropeginterferon alfa-2b is a NEW ACTIVE SUBSTANCE as it differs significantly in properties with regard to safety and efficacy from interferon alpha-2b contained in medicinal product(s) previously authorised within the European Union due to differences in molecular structure, nature of the source material or manufacturing process.

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Polycythaemia Vera (PV) ¬õ¦å²y¼W¥Í¯g

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6.2Therapiemodalitäten

6.2 ªvÀø¤è¦¡

6.2.1 Allgemeine Maßnahmen

6.2.1 ¤@¯ë±¹¬I

Gewichtsnormalisierung, regelmäßige Bewegung, Vermeiden von Exsikkose und langem Sitzen (ggf. Kompressionsstrümpfe, insbesondere bei Reisen), Reduktion von Risikofaktoren und effektive Behandlung kardiovaskulärer Erkrankungen, kein Nikotinkonsum.

¼Ð·ÇÅé­«¡A©w´Á¹B°Ê¡AÁקK¥~¶Ë©Mªø®É¶¡¤[§¤¡]¥²­n®É¿ï¾Ü¼u¤OÄû¡A¯S§O¦b®È¦æ®É¡^¡A´î¤Ö¦MÀI¦]¯À©M¦³®ÄªvÀø¤ß¦åºÞ¯e¯f¡A¤£¨Ï¥Î¥§¥j¤B¡C

6.2.2Aderlass

6.2.2©ñ¦å

Aderlässe sind die schnellste und einfachste Maßnahme zur Absenkung des Hämatokrit und der Beseitigung der Hyperviskosität. Empfohlen werden isovolämische Aderlässe von 500 ml (bei Beginn evtl. von 300 ml) je nach individueller Verträglichkeit ein- bis zweimal pro Woche, bis der Hämatokrit (geschlechtsunabhängig) unter 45% eingestellt ist [27]. Wie durch eine randomisierte Studie belegt wurde (CYTO-PV Studie), konnte durch eine stringente Einstellung des Hämatokrit unter 45% und eine Kontrolle der Leukozytenzahl eine signifikante Absenkung der Thromboembolierate erreicht werden. Damit verbunden war auch eine Reduktion der kardiovaskulären und durch andere größere thrombotische Ereignisse verursachten Mortalität [28, 29]. Die im Verlauf erforderliche Aderlassfrequenz ist den Hämatokrit-Werten individuell anzupassen. Gelegentliche Aderlässe können ergänzend zur zytoreduktiven Therapie erforderlich sein, um den Hämatokrit im gewünschten Bereich zu halten, falls eine Änderung der zytoreduktiven Therapie nicht möglich oder geboten erscheint.

Der immer eintretende Eisenmangel ist „erwünscht¡§ und wird nicht substituiert. In Ausnahmefällen, keinesfalls routinemäßig, kann bei symptomatischem Eisenmangel unter strenger Indikationsstellung und engmaschiger Laborkontrolle eine vorsichtige, orale Eisensubstitution durchgeführt werden. Der zunehmende Eisenmangel ist nicht selten von einem Thrombozytenanstieg begleitet.

Als Alternative zu Aderlässen kann die Erythrozytapherese eingesetzt werden. Ihre Durchführung ist nur an dafür ausgestatteten Einrichtungen möglich.

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¦pÁ{§ÉÀH¾÷¬ã¨s¡]CYTO-PV¬ã¨s¡^©ÒÃҹꪺ¨º¼Ë¡A³q¹LÄY±±¦å®e¤ñ§C©ó45¢H¨Ã±±¨î¥Õ¦å²y¼Æ¶q¡A¥i¥HÅãµÛ­°§C¦å®êµo¥Í²v¡A¦Ó³o»P¤ß¦åºÞ¦º¤`²v©M¨ä¥L¥D­n¦å®ê§Î¦¨¨Æ¥óªº´î¤Ö¦³Ãö¡C

©ñ¦åÀW²v¶·®Ú¾Ú­ÓÅé½Õ¾ã¡C¦pªG²Ó­M´î·ÀªvÀøµLªk¦³©Ò«OÃÒ¡A«h°£¤F²Ó­M´î·ÀªvÀø¥~¡A¥i¯àÁٻݭn°¸º¸©ñ¦å±N¦å®e¤ñºû«ù¦b©Ò»Ý½d³ò¤º¡C

¥Ã»·¦s¦bªº¯ÊÅK¬OµLªk³Q´À¥N¡C¦b¯S®í±¡ªp¤U¡Aµ´¤£¬O±`³W¡A¦bÄY®æ¾AÀ³¯g©MÄY±Kªº¹êÅç«Ç±±¨î¤U¡A¥i¥H³q¹L¯gª¬©ÊÅK¯Ê¥F¶i¦æ¥J²Óªº¤fªAÅK´À¥N¡C¼W¥[¯ÊÅK³q±`¦ñÀHµÛ¦å¤pªOªº¼W¥[¡C

¯f±w·|¸g±`©Êªº¯ÊÅK¡A¦b«D±`³Wª¬ºA¤U¥H¤ÎÄY®æ±±¨î¤U¡A¥i¥H³q¹L¯ÊÅK¯gª¬¶i¦æ¤fªAÅK´À¥N¡C¯ÊÅK³q±`¦ñÀHµÛ¦å¤pªOªº¼W¥[¡C©ñ¦åªº´À¥N¤è®×¡A¥i¥H¨Ï¥Î¬õ¦å²y¦å²G¤ÀÂ÷³N¡C¥u¦³¦b¬°¦¹¥Øªº¦³¬Û¹ïÀ³ªº³]¬I¤¤¤~¯à¹ê¦æ¡C

6.2.3Thrombozytenaggregationshemmer

6.2.3§Ü¾®¦åÃĪ«

Niedrig dosierte Azetylsalizylsäure (‚low dose Aspirin¡¥, ASS) 100 mg/Tag, ist bei Patienten ohne Kontraindikationen gegen das Medikament (Ulkusanamnese, vorausgegangene Blutungskomplikationen u.a.) zur Primärprophylaxe von Thrombosen indiziert, unabhängig davon ob gleichzeitig eine zytoreduktive Therapie durchgeführt wird [4]. Periphere und zerebrale Mikrozirkulationsstörungen sind eine symptombezogene Indikation für ASS [30].

Bei einer Thrombozytenzahl über 1 Million/µl sollte ASS wegen des erhöhten Blutungsrisikos erst nach einer medikamentösen Absenkung der Thrombozytenzahl (wünschenswert unter 600 000/µl) verabreicht werden. Manche Institutionen schließen die Höhe der von Willebrand Faktor-Aktivität in die Entscheidung bzgl. des Therapiebeginns von ASS ein.

Zum Einsatz anderer Thrombozytenaggregationshemmer (z.B. ADP-Antagonisten) gibt es positive Erfahrungen an individuellen Fällen, aber keine gesicherten Daten.

µL½×¬O§_¶i¦æ¤F²Ó­M´î·ÀªvÀø¡A§C¾¯¶qªü´µ¤ÇÆF¡A100²@§J/¤Ñ¡^¾A¥Î©ó¹ï¸ÓÃĪ«µL¸T§Òªº¯f±w¡]¼ìºÅ¯f¥v¡A¥ý«e¥X¦å¨Öµo¯g¡^¡C¦P®É¸£³¡¡B­GÖß½¤¥X¦å¬O¤AñQ¤ô·¨»Ä(ASA)ªº¯gª¬¬ÛÃö¯S¼x¡C

·í¦å¤pªO¼Æ¶q¶W¹L1¦Ê¸U/ul®É¡A¤AñQ¤ô·¨»Ä(ASA)À³¶È¦b¦å¤pªO¼Æ¶q­°§C«á­°§CÃĪ«¾¯¶q¡]³Ì¦n§C©ó600,000 /£gl¡^¡A¦]¬°¥X¦å­·ÀI¼W¥[¡C¤@¨Ç¾÷ºc¦bÃö©ó¤AñQ¤ô·¨»Ä(ASA)ªvÀø¶}©l«e·|°Ñ¦ÒvWF activityªº°ò·Ç¡C¨ä¥L§Ü¦å¤pªOÃĪ«¡]¨Ò¦p¡AADP§Ü¾®¦åÃĪ«¡^¹ï­ÓÅé¯f¨Ò¨ã¦³«Ü¦nªº®ÄªG¡A¦ý¨S¦³¥i¾a¼Æ¾Ú¤ä«ù¡C

6.2.4Zytoreduktive Therapie

6.2.4 ²Ó­M´î·ÀÀøªk

Bereits stattgehabte Thromboembolien und höheres Lebensalter (über 60 bzw. 65 Jahre) sind gesicherte Risikofaktoren für das Auftreten von Gefäßkomplikationen. Jeder dieser Parameter stellt primär eine Indikation zur Einleitung einer zytoreduktiven Therapie dar (Hochrisiko-Patienten).

Auch bei Niedrig-Risiko-Patienten können sich im Krankheitsverlauf Gründe ergeben, eine zytoreduktive Therapie zu beginnen oder diese in Betracht zu ziehen. Diese umfassen insbesondere die Progression der Myeloproliferation, ein steigendes Risiko für Thromboembolien und Blutungen sowie anderweitig nicht kontrollierbare belastende klinische Symptome [26, 27, 31]. Mit Ausnahme von neu aufgetretenen Thrombosen stellen die im Kapitel 6.2.4.1 dargestellten Parameter jedoch keine zwingende Indikation für die Einleitung einer zytoreduktiven Therapie dar. Auch hinsichtlich der Zeichen der Progression der Myeloproliferation gibt es keine exakten Schwellenwerte für den Beginn einer zytoreduktiven Therapie, sodass hier auch die individuelle Proliferationskinetik zu berücksichtigen ist. Die in der Praxis empfohlenen Parameter sind nachfolgend zusammengefasst [27].

´¿¦³¦å®ê®ê¶ë¯f¥v©M¦~ÄÖ¸û¤j¡]¶W¹L60©Î65·³¡^ªº¯f±w¬O¦³¦åºÞ¨Öµo¯gªº°ª¦MÀI¸s¡C³o¨Ç°ª­·ÀI¯f±w¥D­n¬°²Ó­M´î·ÀªvÀø±Ú¸s¡C

§Y¨Ï¦b§C­·ÀI¯fªÌ¡A¤]¥i¯à¦³­ì¦]¦Ò¼{²Ó­M´î·ÀªvÀø¡A¥]¬A°©Åè¼W¥Í©Ê¯e¯fªº´c¤Æ¡B¦å®ê®ê¶ë©M¥X¦åªº­·ÀI¼W¥[¥H¤Î¨ä¥L¤£¥i±±ªºÁ{§É¯gª¬¡CµM¦Ó¡A°£¤F·sµo¥Íªº¦å®ê¥~¡A²Ä6.2.4.1³¹¤¤ªº°Ñ¼Æ¨Ã¤£¬O¶}©l²Ó­M´î·ÀªvÀøªº±j¨î©Ê­n¥ó¡C¨S¦³©ú½T±Ä¥Î²Ó­M´î·ÀÀøªkªº¤è¦¡¡A¥²¶·¦Ò¼{­ÓÅé¼W´Þ°Ê¤O¾Ç¡C¹ê»Ú¤¤±ÀÂ˪º°Ñ¼ÆÁ`µ²¦p¤U¡C

6.2.4.1Parameter zur Einleitung einer zytoreduktiven Therapie

6.2.4.1 ¨Ï¥Î²Ó­M´î·ÀÀøªkªº°Ñ¼Æ

Zeichen der Progression der Myeloproliferation

• Zunahme der Milzgröße oder symptomatische Splenomegalie

• Thrombozytenanstieg auf > 1 000 000/µl

• Leukozytenanstieg auf > 10 000/µl bis > 15 000/µl oder höher

• Häufige bzw. zunehmende Aderlassfrequenz

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• µÊŦÅܤj©Î¯gª¬©ÊµÊ¸~¤j

• ¦å¤pªO¼W¥[¦Ü> 1000000 /£gl

• ¥Õ¦å²y¼W¥[¦Ü> 10 000 /£gl ¦Ü > 15 000 /£gl©Î§ó°ª

• ÀW²v¼W¥[

Gesteigertes/zunehmendes Risiko für Thromboembolien und Blutung und nicht kontrollierbare belastende klinische Symptome

• Im Verlauf neu aufgetretene Thromboembolien

• Hämorrhagische Komplikationen

• Mikrozirkulationsstörungen trotz ASS

• Eingeschränkte Durchführbarkeit von Aderlässen

• Symptomatischer Eisenmangel, der eine Fortführung der Aderlässe nicht erlaubt

• Unkontrollierter Hämatokritanstieg, falls Eisensubstitution unumgänglich ist

• Schwere bzw. den Patienten belastende krankheitsbedingte Symptome

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6.2.4.2Zytoreduktive Therapieformen

6.2.4.2 ²Ó­M´î·ÀÀøªk

6.2.4.2.1Primärtherapie

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Die von Seiten der ELN-Expertengruppe empfohlene zytoreduktive Primärtherapie ist Hydroxyurea (Hydroxycarbamid) oder Interferon alpha (siehe Abbildung 1) [27]. Die (insbesondere anfänglich) ggf. notwendige Fortführung der Aderlasstherapie ist von den individuellen Blutwerten abhängig zu machen.

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Hydroxyurea (Anfangsdosis: 15-20 mg/kg KG/Tag). Eine individuelle Anpassung an die Blutwerte ist vorzunehmen. Im Rahmen des European LeukemiaNET wurden Kriterien zur Bewertung des Therapieansprechens auf zytoreduktive Therapie sowie von Resistenz und Intoleranz von Hydroxyurea erarbeitet (siehe Tabelle 7). Diese stellen Konsensusempfehlungen dar und sollen Hilfestellung bei der Bewertung des Therapieansprechens und bei eventuell erforderlichem Therapiewechsel geben [32, 33].

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Interferon alpha (IFN): IFN wird von der ELN-Expertengruppe für die Primärtherapie der PV ohne definiertes Alterslimit alternativ zu Hydroxyurea empfohlen [27]. Eine besondere Zielgruppe für IFN sind jüngere Patienten mit Kinderwunsch. Die herkömmliche Form von IFN (Anfangsdosis: 3 x 3 Mio. IE/Woche s.c.) wurde weitgehend von der pegylierten Form abgelöst. Die Anpassung der IFN-Dosis erfolgt nach Blutbild und Verträglichkeit [34]. Bisher im Handel verfügbares pegyliertes Interferon wird nur einmal wöchentlich verabreicht (IFN alfa 2a, Pegasys®, durchschnittliche Dosierung 90µg pro Woche) Hauptproblem von IFN ist die oft eingeschränkte Verträglichkeit, die nicht selten zum Therapieabbruch führt [34, 35]. Eine neue, bisher nur in Studien eingesetzte Form des pegylierten IFN (Ropeginterferon alfa-2b) mit längerer Wirkdauer erlaubt eine Applikation in 14-tägigem Abstand [36, 37]. Die Dreijahresdaten der randomisierten Zulassungsstudie bei unbehandelten oder mit Hydroxyurea vorbehandelten Patienten zeigten eine signifikante Überlegenheit von Ropeginterferon gegenüber Hydroxyurea oder bester verfügbarer Therapie (BAT) hinsichtlich der Rate an kompletter hämatologischer Remission sowie der Reduktion der Allel-Last. Ropeginterferon alfa-2b ist das derzeit einzige für die Therapie der PV zugelassene Interferon-Präparat (Zulassung in der EU im Februar 2019, siehe Anlage Zulassungsstatus).

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Tabelle 7: ELN-Definition der Resistenz oder Intoleranz gegenüber Hydroxyurea (HU) bei PV [32]

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# Aderlassbedürftigkeit nach 3-monatiger Therapie mit mindestens 2g HU/Tag, um den Hämatokrit unter 45% zu halten oder

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# Unkontrollierte Myeloproliferation (d.h. Thrombozyten >400 000/µl oder Leukozyten >10 000/µl) nach 3 Monaten Therapie mit mindestens 2g HU/Tag oder

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# Milzgrößenreduktion unter 50% bei massiver1 Splenomegalie (Beurteilung durch Palpation) oder unvollständiges Verschwinden von durch die Splenomegalie bedingten Symptomen nach 3-monatiger Therapie mit mindestens 2g HU/Tag oder

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# Absolute Neutrophilenzahl <1 000/µl oder Thrombozytenzahl <100 000/µl oder Hämoglobin <10g/dl mit der niedrigsten Dosis von HU, die erforderlich ist, um ein komplettes2 oder partielles3 klinisch-hämatologisches Ansprechen zu erzielen oder

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# Ulcera an den Beinen oder andere inakzeptable HU-bedingte nicht-hämatologische Toxizitäten, wie andere Manifestationen an Haut oder Schleimhäuten, gastrointestinale Symptome, Pneumonitis oder Fieber unabhängig von der Dosierung von HU.

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April 2019§ó·s PV«ü¤Þ

www.onkopedia.com/de/onkopedia/guidelines/polycythaemia-vera-pv/@@view/html/index.html

(Ropeginterferon alfa-2b)¦b 6.2.4.2.1Primärtherapie

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2.­^¤å:onlinelibrary.wiley.com/doi/pdf/10.1111/bjh.15648

Recommendations: Management options in high-risk patients

• First Line: hydroxycarbamide (HC) or interferon (preferably pegylated interferon)

• Second line: in patients treated with HC as first line, interferon as second line treatment, or,

where treated with interferon as first line, recommend HC as second line treatment

• Consider pegylated interferon as second line in those patients who have had non-pegylated

interferon first line and could not tolerate it

• Ruxolitinib second/third line in HC resistant or intolerant patients (GRADE 1A)

Third-line or further treatment options

• Busulfan or 32P or pipobroman in those with limited life expectancy (GRADE 1B).

• Anagrelide in combination with HC may be helpful in those where platelet control is difficult

(GRADE 2C)

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[What is the estimated number of patients affected by the condition?

At the time of designation, polycythaemia vera affected approximately 3 in 10,000 people in the European Union (EU)*. This is equivalent to a total of around 152,000 people, and is below the ceiling for orphan designation, which is 5 people in 10,000. This is based on the information provided by the sponsor and the knowledge of the Committee for Orphan Medicinal Products (COMP).

..... This represents a population of 506,300,000 (Eurostat 2011).]

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-------------------------------

More information on Glivec(°ò§Q§J)

This product is no longer an orphan medicine. It was originally designated an orphan medicine for the following orphan indications:

treatment of chronic myeloid leukaemia (14/02/2001);

treatment of malignant gastrointestinal stromal tumours (20/11/2001);

treatment of dermatofibrosarcoma protuberans (26/08/2005);

treatment of acute lymphoblastic leukaemia (26/08/2005);

treatment of chronic eosinophilic leukaemia and the hypereosinophilic syndrome (28/10/2005);

treatment of myelodysplastic / myeloproliferative diseases (23/12/2005).

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www.ncbi.nlm.nih.gov/pubmed/23768070

Myelofibrosis (MF), polycythemia vera (PV) and essential thrombocythemia (ET) are three classic BCR ABL fusion gene-negative chronic myeloproliferative neoplasms (MPNs). Though rare, it is important to understand the burden of illness of these disorders for public health planning, healthcare insurers and pharmaceutical manufacturers. Therefore, we have described the incidence of MF and prevalence of MF, ET and PV in the United States between 2008 and 2010 based on data from two large health plans. The incidence of primary MF was about 1 per 100 000 per year and did not vary over the study years. The prevalence of PV (44-57 per 100 000) and ET (38-57 per 100 000) was much higher than that of MF (4-6 per 100 000) or subgroups containing MF (post-PV MF = 0.3-0.7 per 100 000; post-ET MF = 0.5-1.1 per 100 000). Additional research using other national databases and/or study designs is needed to substantiate these findings

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[·|­û¡GAlan Liu10136094 µoªí®É¶¡:2019/5/9 ¤U¤È 01:37:50²Ä 6646 ½g¦^À³

Jakavi ¦bEU ¤]ºM¾P©t¨àÃĸê®æ www.ema.europa.eu/en/medicines/human/EPAR/jakavi ]

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·|­û¡GAlan Liu10136094  µoªí®É¶¡:2019/5/9 ¤U¤È 01:37:50²Ä 6645 ½g¦^À³
Jakavi ¦bEU ¤]ºM¾P©t¨àÃĸê®æ

www.ema.europa.eu/en/medicines/human/EPAR/jakavi

More information on Jakavi

§ó¦h¦³Ãö©óJakavi ªº¸ê°T

This product is no longer an orphan medicine. It was originally designated an orphan medicine for the following orphan indications:

¸Ó²£«~¤£¦A»{©w¬°©t¨àÃÄ¡C¥¦³Ìªì³Q«ü©w¬°¥H¤U¾AÀ³¯gªº©t¨àÃÄ¡G

treatment of chronic idiopathic myelofibrosis (07/11/2008);

2008¦~11¤ë7¤é ªvÀø­ìµo©Ê°©ÅèÅÖºû¤Æ

treatment of myelofibrosis secondary to polycythaemia vera or essential thrombocythaemia (03/04/2009);

2009¦~4¤ë3¤é ªvÀøÄ~µo©Ê¬õ¦å²y¼W¦h¯g©Î¦å¤pªO¼W¦h¯gªº°©ÅèÅÖºû¤Æ¡]03/04/2009¡^

treatment of polycythaemia vera (19/02/2014).

2014¦~2¤ë19¤é ªvÀø PV

Jakavi in treatment of chronic idiopathic myelofibrosis and treatment of myelofibrosis secondary to polycythaemia vera or essential thrombocythaemia was withdrawn from the Community Register of designated orphan medicinal products in February 2015 upon request of the marketing authorisation holder.

®Ú¾Ú¤W¥«¾P°â«ù¦³ªÌªº­n¨D¡AJakavi©ó2015¦~2¤ë±q©t¨àÃIJ£«~µn°O¤¤ºM¾P¤FªvÀø­ìµo©Ê°©ÅèÅÖºû¤Æ©MªvÀøÄ~µo©ÊPV©ÎETªº°©ÅèÅÖºû¤Æ¡C

Jakavi in treatment of polycythaemia vera was withdrawn from the Community register of orphan medicinal products in February 2015 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.

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®Ú¾Ú³ø§iªº¤º®e¡A

www.ema.europa.eu/en/documents/orphan-maintenance-report/besremi-epar-withdrawal-assessment-report-orphan-maintenance_en.pdf

The proposed therapeutic indication in the MAA is ¡§Treatment of polycythaemia vera in adults withoutsymptomatic splenomegaly¡¨. The proposed therapeutic indication falls entirely within the designated orphan condition which is broadly worded as ¡§treatment of polycythemia vera¡¨.

¤j­n¬O»¡¡A¾A¥Î¼s¸qªºPV¡A³o¾A¥Î¯g¤w¤£¦b©t¨àÃĪº½d³òùØ¡C

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AOP removal request 18 December 2018

²Î¤@¤j¤á´N¨º»ò¥©¦Xªº±q2018.12.17¶}©l½æ¥X!

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Ãø©Ç¨úÃÒ«áªÑ»ù¤Ï¦Ó¤U±þ.

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1.Sponsor¡¦s removal request18 December 2018

Following communication of the outcome of the discussion, the sponsor fomally requested the withdrawal of the orphan designation on 18 December 2018, prior to final opinion.

www.ema.europa.eu/en/documents/orphan-maintenance-report/besremi-epar-withdrawal-assessment-report-orphan-maintenance_en.pdf

2.More information on Besremi

This product is no longer an orphan medicine. It was originally designated an orphan medicine on 9 December 2011.

Besremi was withdrawn from the Community register of orphan medicinal products in December 2018 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.

www.ema.europa.eu/en/medicines/human/EPAR/besremi

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±q¥þ²y¦å²G¯e¯fªº±M®a³ø§i¥H¤Î¥H¤Uªº¸ê®ÆÅã¥Ü, Ropeginterferon alpha-2b ÃĵØÃÄ·s¤@¥N¤zÂZ¯ÀP1101, ¥¼¨Ó±N¤Þ»â¥þ²y¦å²G¯e¯fªvÀø¤§¨Ï©R¡C

Pegasys interferon shortage

ªø®Ä«¬¤zÂZ¯À(ù¤óPegasys) µu¯Ê

healthunlocked.com/mpnvoice/posts/140672434/pegasys-interferon-shortage?uid=c8bfda7f-c70a-4f22-a4bb-ade56c670522&utm_campaign=mpnvoice&utm_medium=email&utm_source=notification&utm_term=new-daily+digest

Spam1979¡G

Hi,

Had my monthly haematology check up the other day and my consultant advised that there is a manufacturing shortage of peg interferon at the moment so they couldn¡¦t prescribe my normal 4 weeks supply. Has anyone else heard this or is it maybe just a Scotland thing?

I¡¦ve to go back on Friday as they could only prescribe 1 week last time, and if they haven¡¦t managed to source it yet I may need to move over to hydroxycarbamide until they can source more which worries me a bit. Has anyone else made this transition and what was your experience? I¡¦m a 39 year old female with PV.

Hi, §Ú¨C­Ó¤ë¶i¦æ¦å²GÀˬd, §ÚªºÅU°Ý´£¨ì¥Ø«eªø®Ä«¬¤zÂZ¯À(ù¤óPegasys)µu¯Ê¡A©Ò¥H¥L­ÌµLªk¥¿±`¶}¥X¥|©PÀøµ{ªºªvÀø¥ÎÃÄ¡C¦³¨S¦³¤HÅ¥¹L³o­ÓÁÙ¬O¥¦¥uµo¥Í¦bĬ®æÄõ¡H§Ú±N¦b©P¤­¦^¥h¡A¦]¬°¥L­Ì¥u¯à¶}¥ß¤@©P³B¤è¡A¦pªG¤´¨S¦³¿ìªk¨ú±oªº¸Ü¡A§Ú¥i¯à­nÂà¨ìHU¡C¦³µL¨ä¥L¤H´¿³o¼ËÂàÅÜ¡A¦Ó§A­Ìªº¸gÅç¬O¤°»ò¡H§Ú¬O¤@¦W39·³¿©±wPVªº¤k©Ê¡C

Cja1956¡G

I have PV but have never done interferon. I also have ET so I take hydroxyurea for the ET and jakafi for PV which works pretty well. Hydroxy stopped working on my platelets after eight years on it so That¡¦s why my doctor put me on Jakafi which helps a lot. But I¡¦m older than you and I¡¦ve heard on this site that doctors treat us differently due to our ages.

Hope this helps.

§Ú¬O¯u©Ê¬õ¦å²y¼W¥Í¯g(PV)¯f±w¡A¦ý±q¥¼¨Ï¥Î¤zÂZ¯ÀªvÀø¡C§Ú¤]¦P®É¤]¿©±w¦å¤pªO¼W¥Í¯g(ET)¡A©Ò¥H§Ú¥ÎHUªvÀø¦å¤pªO¼W¥Í¯g(ET)¡A¦ÓJAKAFi¥Î©óªvÀø¯u©Ê¬õ¦å²y¼W¥Í¯g(PV)¡AÀø®Ä«Ü¦n¡C¤K¦~«á¡AHU¹ï§Úªº¦å¤pªO¼W¥Í¯g(ET)ªvÀøµL®Ä¡A¦]¦¹Âå¥Í±NJakafiªvÀø¥Î©ó§Ú¨­¤W¡A³o¹ï§Ú¦³«Ü¤jªºÀ°§U¡C§Ú¦~¬ö¤ñ§A¤j¡A§Ú´¿¦b³o­Óºô¯¸¤WÅ¥»¡¹L¡AÂå¥Í·|®Ú¾Ú§Ú­Ìªº¦~ÄֱĥΤ£¦Pªº¥ÎÃÄ«Øij¡C

§Æ±æ³o¥i¥HÀ°§U©p¡C

MPort

19 hours ago

Hi, that¡¦s sounds worrying. But I wonder and HOPE if it is a supply problem. For the past year I haven¡¦t been given my full perscription. This has only been on 4 occasions and I get the next 4 months so I need about 12 injections. I get to pharmacy after 12 and they can only give me 1 or 2. I go back when they phone me and get the remainder. I always ask them why but they have no interest in giving a reason. I will bring it up at next appointment. Let¡¦s hope it is just a blip.

Mairead

³oÅ¥°_¨Ó«Ü¥O¤H¾á¼~¡C§Ú¤]·Qª¾¹D¨ÑÀ³¬O§_¬O­Ó°ÝÃD¡C¦b¹L¥hªº¤@¦~¸Ì¡A§Ú±q¥¼±o¨ì§¹¾ãªº³B¤è¡C§Ú¥u¯àª`®g4¦¸¡A¦ý§Ú±µ¤U¨Óªº4­Ó¤ë¤j¬ù»Ý­n12¦¸ª`®g¡C¦b12¦¸ª`®g«á§Ú¥h¤FÃħ½¦ý¥L­Ì¥u¯àµ¹§Ú1©Î2¾¯¡C·í¥L­Ìµ¹§Ú¥´¹q¸Üªº®É­Ô§Ú¤~¯à¦^¥h®³³Ñ¾lªº¡C§Ú°Ý¥L­Ì¬°¤°»ò¡A¦ý¥L­Ì³£¨Sµ¹¥X²z¥Ñ¡C§Ú·|¦b¤U¦¸¹w¬ù¬Ý¶E®É´£¥X¨Ó¡C

§Æ±æ³o¥u¬O°¸µo²{¶H¡C

Jocko

19 hours ago

Hi,

I am on Peg and aspirin. I get prescription for Peg every 3 months. Peg is working really well for me and I do not want to go on HU. If that were to happen I think I would ask my consultant if I could stick to aspirin until Peg was available. It must take a while for the platelet count to rise back up so I guess it wouldn¡¦t be too bad for a few weeks.

I hope it works out for you whatever you decide.

Good luck

Hi¡A

§Ú¨Ï¥Îªø®Ä«¬¤zÂZ¯À(ù¤óPegasys)©Mªü´µ¤ÇÆFªvÀø¡C§Ú¨C¹j3­Ó¤ë¨ú±oªø®Ä«¬¤zÂZ¯À(ù¤óPegasys)³B¤è¤@¦¸¡Cªø®Ä«¬¤zÂZ¯À(ù¤óPegasys)¹ï§Ú¨Ó»¡«D±`¦n¡A§Ú¤£·QÄ~Äò¨Ï¥ÎHU¡C¦pªGµo¥Í³oºØ±¡ªp¡A§Ú·Q§Ú·|½Ð±Ð§ÚªºÅU°Ý¡A§Ú¬O§_¥i¥H°í«ù¨Ï¥Îªü´µ¤ÇÆFª½¨ìªø®Ä«¬¤zÂZ¯À(ù¤óPegasys)«ì´_¨ÑÀ³¡C¦å¤pªO¼Æ¦r­n¦^¤É¤]»Ý­n¤@¬q®É¶¡¡A©Ò¥H§Ú·Q³o´X¶gÀ³¸Ó¤£·|¤ÓÁV¿|¡C

§Ú§Æ±æµL½×§A¨M©w¤°»ò¡A¤W­z¸ê°T³£¹ï©p¦³À°§U¡C

Susana7

18 hours ago

That¡¦s really worrying... Pegasys availability is an ongoing source of concern for me in the current situation. If it were me, I would ask to take a short Pegasys break rather than transition to HU. I had no problems with my last Peg prescription in February, but am due in clinic in 2 weeks so will know more then. Ask your haemo if you can keep a couple of extra injections for situations such as this. Maybe they can source interferon from a different manufacturer or buy vials rather than pre-filled syringes, if there is more availability. Good luck and let us know how you get on. Susana x

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SueWhelan

17 hours ago

The hospital pharmacy will only give me 4 weeks at a time even though I have a prescription for 3 months. I have to go back each time to collect. They only order it in the week I am due. Not sure why. If it is shortage or hospital policy?

I know there was a shortage of interferon a while ago as I was on that, couldn¡¦t get it for a few days and the pharmacy had to source from another hospital.

I have been told that pegalated interferon will no longer be prescribed (ie not licensed) for MPNs, though those people already on it can continue. Also not sure of the reasons?

It is a little worrisome.

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swimswam

17 hours ago

I was told Pegasys wasn¡¦t approved for ET, so I have to use the old fashioned Interferon, I suppose that could be an alternative if you can¡¦t get Peg.

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Anag

14 hours ago

Hi Spam, there are sometimes shortages. My husband¡¦s meds were out for 9 months last year in Austria. Not funny. I always try to keep a 4 month stock at home. Just in case.

Hi, Spam, ¦³®É·|µu¯Ê¡C§Ú¤V¤Ò¦b¶ø¦a§QªºÃħ½¥h¦~¤w¸g¦³9­Ó¤ë¨S³f¤F¡C§ÚÁ`¬O¸ÕµÛ§â4­Ó¤ëªº®w¦s¯d¦b®a¸Ì¥H¨¾¸U¤@¡C

Charlieapple2018

14 hours ago

I was only allowed 4 wks supply and had to return to the hospital to collect the 5th week between consultant meetings. I think the hospital only has a certain number in and has to order. I didn¡¦t consider that there was a shortage, I thought it was just policy.

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......SueWhelan 4 hours ago...

....[I have been told that pegalated interferon will no longer be prescribed (ie not licensed) for MPNs,though those people already on it can continue. Also not sure of the reasons? ]

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..........

SueWhelan 4 hours ago...

....[I have been told that pegalated interferon will no longer be prescribed (ie not licensed) for MPNs,though those people already on it can continue. Also not sure of the reasons? ]

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·|­û¡GAT10147586  µoªí®É¶¡:2019/5/7 ¤U¤È 09:35:32²Ä 6611 ½g¦^À³
Ruxolitinib Combos Explored to Address MPN-Associated Symptoms

Published: Monday, May 06, 2019

www.onclive.com/web-exclusives/ruxolitinib-combos-explored-to-address-mpn-associated-symptoms?p=1

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2. Myeloproliferative°©Åè¼W¥Í¯gª¬·|²£¥Íanemia³h¦å¯gª¬, µM¦Ó·í¨Ï¥ÎRuxolitinib (Jakafi) ®É°£¤F²£¥Í§óÄY­«ªº³h¦åanemia²{¶H¥~, blast cell (¤£¦¨¼ô¦å²yªÞ²Ó­M) ¼W¥Í°ÝÃD¤]¬O§@ªÌ¦b¥»¤å´£¨ìJakafi¦bMFªº¥t¤@­Ó°ÝÃD

3. MD. Laura Michaelis¤å¤¤´£¨ì, ¤zÂZ¯À¨ì©³¬O§_»Ý­n¦bMPN MFªºªì´Á´N±Ä¥Î»P§_¤w¦b¦U¬ÉÅG½×¤¤ (µ§ªÌ¦¬¶°¨ìªº2018/10¤ë¦³¤@³õµÛ¦Wªº¾Ç³NÅG½× presentation summary ½Ð¸Ôªþµù)

4. Q: How would you define the role of interferon today? ¤zÂZ¯Àªº¨¤¦â©w¦ì?

As you know, most of the randomized data for the past 3 decades in PV has utilized hydroxyurea as one of the primary arms. However, there is increasing use of interferon, especially in patients who are JAK2-positive. We have early hints that over time, patients¡¦ molecular mutation burden might decline with the use of interferon. One of the big landmarks in MPNs was the publication in the National Comprehensive Cancer Network guidelines of treatment recommendations for these diseases. They did indicate that interferon was an appropriate frontline choice for some

individuals.

¹L¥h30¦~¦bªvÀøMPN PV ¥D­n¥HHU¥ÎÃĬ°¥D, ¦ý¬O¤zÂZ¯À¦¨¬°¥D­nªvÀøÃĪ«¦³¼W¥[²{¶H (¤×¨ä·í¯f±w§eJAK-2¶§©Ê), ¦³¨Çªì¨Bªº¬ã¨s¸ê®Æ¤w«ü¥X¡A¯f¤Hªº¤À¤l¸~½F­t¾á·¥¤]¥i¯à¦]¬°¨Ï¥Î¤zÂZ¯À¦ÓÀò±o§ïµ½. ¯S§O¬O¦b¬ü°êÀù¯g¸ê°TºôNCCN (National comprehensive cancer network) ªvÀø«Øij·Ç«h¤¤, ¤zÂZ¯À¦b«Ü¦h±¡ªp¦­¤w³Q¦C¥Ü¬°¾A·íªº«e½u¥ÎÃÄ¿ï¾Ü

5. ¦pªG¦Ò¼{¨ì¯f¯gªvÀø»Ýªø¹F´X¤Q¦~, ¨º»òHUßm°ò脲ªº¥Ö½§¬r©Ê¥i¯à¬O­Ó°ÝÃD¡C¦Ó§Ú(MD Laura Michaelis)½T¹ê§ó³ßÅw¤@¶}©l´N¨Ï¥Î¤zÂZ¯À, ¦]¬°¥¦¥i¥H±o¨ì«Ü¦nªº­@¨ü©Ê, ¯S§O¬O¦b»E¤A¤G¾Jªº§Î¦¡(Pegylated form)¡CA novel interferon- alpha has been introduced in Europe, and we hope that will be the kind of agent that American patients have access to in the future. (¤@ºØ³Ð·sªº¤zÂZ¯À£\ (´N¬O·N¦®ÃĵØRopeginterferon alpha 2b) ¤w¸g¦b¼Ú¬w°Ó·~¤Æ¤F, §Ú­Ì§Æ±æ¬ü°ê±wªÌ§Y±N¥i¥H±µÄ²¨ìªº³oºØÃĪ«!

ªþµù:

Topic: Should Patients with ¡§early¡¨ myelofibrosis be treated with interferon?

(¤zÂZ¯À¬O§_À³¸Ó¦bªì´ÁªºMF°©Åè¼W¥Í¯e¯f®É´N³Q¨Ï¥Î?)

Event:

11th international congress on Myeloproliferative Neoplasms MPN 10/25-26/2018, NY

Debate MD Richard T. Silver (:YES) vs. MD Ronald Hoffman (:NO)

µ²½×: Treatment Implications

1. Early treatment superior to ¡§watchful waiting¡¨. Avoid development of early and advanced MF

2. Consistent with general concept of treating cancer when minimal tumor burden exists

3. Early treatment with rIFN£\ may target both the malignant clone and the chronic inflammatory state in MPN

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Since approval, on November 16 and beginning on November 22 through December 31, we were able to recognize $2 million as net sales in 2011 based on $4.9 million of Jakafi that we shipped to our specialty pharmacies.

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¤@¨Ç¦³Ãö Jakafi ªºµû½×¤À¨É¡G

Jakafi for PV- Hope or Hype?

mpnforum.com/december-18-jakafi-for-pv/

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Jakafi ¬O JAK1, JAK2 §í¨î¾¯¡A¦]¬°µLªk§ïÅܯf±¡´c¤Æªº¥»½è¡A¥u¬O´î¤ÖÅ餺 JAK1, JAK2 ¡AÅý±wªÌ¥H¬°¯f±¡¦nÂà¤F¡C¨Æ¹ê¤W¡A±¡ªp¬O¯fªp¬O«ùÄò´c¤Æªº¡A³o¤]¬O¬°¦ó·í¼W¥[¶q¾¯¥[¤§«á¡A«Ü¦h¤H·|¦]ÄY­«°Æ§@¥Î¾É­P¥²¶·°±ÃÄ¡C

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.www.chinatimes.com/newspapers/20180126000264-260202?chdtv

....Richard T. Silver³Õ¤h±j½Õ¤zÂZ¯À¬O[°fÂà] MPN¶i®iªº°ß¤@¦³®ÄÃĪ«¡A¨Ã´Á³\FDA¥i¥H¾¨§Ö¥¿¦¡®Ö­ã¤zÂZ¯ÀªvÀøMPN----°_ªì¥H¬°³o¬q¸Ü¬O°OªÌ·|¿ù·NÀA¤W²Kªá¤W¥h....

¤@¬dµo²{Dr. Richard T Silver¥H«eµoªí¹L³o¼Ë½×­z:

1.htttp://www.crt.org/Development-of-Interferon-in-MPN-Therapy

....interferon has very specific effects and is the only MPN treatment known to stop or reverse disease of the bone marrow....

2.www.bloodjournal.org/content/117/24/6669?sso-checked=true

Recombinant interferon-£\ may retard progression of early primary myelofibrosis: a preliminary

report Richard T. Silver

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tps://markettrendsnews.com/2019/05/essential-thrombocythemia-drug-market-in-deep-analysis-and-healthcare-experts-review-report-2019-2025/

Essential Thrombocythemia Drug Market In-deep Analysis And Healthcare Experts Review Report 2019-2025

Healthcare

Essential Thrombocythemia Drug Market In-deep Analysis And Healthcare Experts Review Report 2019-2025

AbbVie Inc,

Aop Orphan Pharmaceuticals AG,

F. Hoffmann-La Roche Ltd,

Galena Biopharma Inc,

Incyte Corp,

Italfarmaco SpA,

MEI Pharma Inc,

PharmaEssentia Corp ÃĵØ

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# »{ÃÑ Dr. silver: Interferon ªº¥ýÅXªÌ¤§¤@....

Dr. Richard Silver was the pioneer in IFN-research in PV in the U.S., publishing the first report in 1988.

mpnforum.com/interferon-and-mpns/

# ťť¬Ý¥L¹ïinterferon / Jakafi ¬Ýªk.....

¤£½×¬O§_¥¼¨Óinterferon / Jakafi ¦X¨Ö¥ÎÃÄ·|§ó¦n¡A°Z¦³¤@½u¨Ï¥Î»¹©ó¤G½u¹D²z¡H

HU ÁöµM«K©y¡A¦ý¬OHU ¥iµu¼È±±¨î¯f±¡¡A¦ýµLªk½w¸Ñ/ÁקKMPN ¯e¯f´c¤Æ¡C©Ò¥H¥u­n«OÀI¥i¥Hcover, ¦binterferon ¶V¨Ó¶V¦h¼Æ¾ÚÃÒ©ú¥i¥H´î½wJak2 ¨ÃÁקK´c¤Æ±¡§Î¡A½Ö·|©Úµ´interferon¡HSilver »{¬° ¨Ï¥ÎJakafi ¥u¦³µu´Á§ïµ½¥Í¬¡«~½è¡AµLªk¤¤ªø´Á§ïµ½PV¯f¼x¡A¨Ï¥Î¤­¦~«á¬ù¦³60%·|°±±¼Â÷¶}³o­ÓÃÄ.....

www.onclive.com/publications/milestones-in-medicine/2019/history-and-evolving-role-of-interferon-in-myeloproliferative-neoplasms/mpns-pioneer-highlights-long-lasting-role-of-interferon

Dr. silver said...

.....We believe that there are 2 reasons for using interferon. First, there is a biologic basis for its use, and secondly, it avoids the development of iron deficiency. In addition, there is evidence that interferon can reduce thrombotic risk, which is significant for patients who are only treated with phlebotomy. We also have evidence from more than 300 patients with PV that the fibrosis we see in this disease will have a delayed onset of disease when they are treated with interferon; this is because interferon affects PDGF and TGF£], as well as other cytokines that are responsible for the development of myelofibrosis. This is very exciting, and it is new information; it has never been shown in any population of patients. We presented a poster on this at the 2018 ASH Annual Meeting.

Could you expand on the use of interferon in today¡¦s landscape?

We believe that in the long-term¡Xnot the short-term use¡Xthat hydroxyurea can cause leukemia in about 8% to 10% of patients. In a 15-year span, this number increases to about 15%. A patient can no longer use the drug if he/she develops secondary leukemia. There has never been a controlled study evaluating hydroxyurea over the long-term compared with phlebotomy because most patients cannot stay on phlebotomy.

.....Interferon will significantly reduce the risk of developing secondary leukemia¡Xthis is very important.

..........There is evidence that interferon will also reduce the cellularity of the bone marrow, which is responsible for producing the number of white blood cells, red blood cells, and platelets that we see in PV. We reported on that a couple of years ago as well.

....We also have evidence that interferon will reduce JAK2, the genetic abnormality that characterizes PV. We are not quite sure what that means, because we can see marrow reduction in patients that don¡¦t have significant decreases in JAK2. Anyway, there is evidence that interferon will certainly affect significant parameters of the disease. Lastly, the data from an Austrian group suggest that in a controlled trial, interferon can lead to significant differences in remission rates compared with hydroxyurea [at 1 year]. I would imagine this study will be published relatively soon. Those are the reasons that we believe interferon should have preference over other options in patients with PV. 

Where does ruxolitinib (Jakafi) play into this?

We think ruxolitinib is a useful drug. As you know, it has been FDA approved for its efficacy in intermediate- and high-risk disease. Many doctors prescribe it for patients with earlier-stage myelofibrosis if a patient is symptomatic. Ruxolitinib is very helpful in these patients, but I don¡¦t believe it definitively changes the disease from the standpoint of bone marrow remission. It will make the spleen smaller in a significant number of patients with myelofibrosis at about 30% to 40%. At the end of 5 years, more than 60% are off this drug.

In my view, ruxolitinib re-treats constitutional symptoms such as fatigue, weight loss, and bone pain. I believe it should be used in combination with interferon for the treatment of PV. There are studies from Weill Cornell Medicine about the early use of interferon for biologic abnormalities and the use of ruxolitinib for symptomatic improvement. There is also, perhaps, biologic synergy between these 2 agents. 

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2016 0.55 $107

2017 (1.53) $148

2018 0.52 $99.85

2019 $88

2017 Á٬ƦܬO­t­È¡A«oªÑ»ù­ËUSD 148.......

§Y¨Ï¬Q¤é¤]¦b$80 ¥ª¥k.......

PV ¤@½u¥ÎÃÄÁÙ¦b¬üª÷$5 ¥´²V.....

¬ü°ê¶R Incyte ªº ¥~¸êªk¤HÁÙ¦bºÎı¡H ÁÙ¬O Incyte ¨ä¥¦²£«~½u «e´º¦n? (question!)

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Anyway, Wait and See..........

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·|­û¡GAT10147586  µoªí®É¶¡:2019/4/26 ¤U¤È 10:14:40²Ä 6544 ½g¦^À³
4th MPN Asia will be held on 4/27 (Sat) Korea. (Pharmaessentia Ãĵزĥ|¦~¥D¿ì)

mpnasia.com/site/mypage.aspx?pid=202&lang=en&sid=1206

Key topics:

Why MPNs Should be Treated with Interferon Sooner, Not Later

Dr. Richard T. Silver

Clinical Endpoints and Treatment Goals in Managing MPNs

Dr. Jean-Jacques Kiladjian

Emerging Treatments for MPNs

Dr. Ruben A. Mesa

Beyond JAK2 V617F

Dr. Yoko Edahiro

Interferon Therapy in Myeloproliferative Neoplasms

Dr. Abdulraheem Yacoub

Ropeginterferon alfa-2b versus Hydroxyurea for the Treatment of PV, a Randomized Phase III Trial: the Basis for Ropeginterferon Approval in Europe

Dr. Heinz Gisslinger

Real-World Experience of Ropeginterferon alfa-2b in MPN

Dr. Chih-Cheng Chen

Myeloproliferative Neoplasms Survey in China

Dr. Qian Jiang

Clinical Features and Outcomes of Patients with Primary Myelofibrosis in Japan

Dr. Katsuto Takenaka

Pediatric MPN in Japan

Dr. Akira Shimada

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·|­û¡GAT10147586  µoªí®É¶¡:2019/4/26 ¤U¤È 09:15:09²Ä 6543 ½g¦^À³
ÁöµMÁÙ¦bphase2, ¦ý¬O¤]¬O¦³ÃöP1101 ¦bMF °©ÅèÅÖºû¤Æªº¤@¨Ç (¥¿­±)°T®§....

ÃĵØP1101 ¦b¬ü°êµÛ¦W±ö¬ùÂå°|¶i¦æ¾AÀ³¯gMF°©ÅèÅÖºû¤ÆÁ{§É¤G´Á.

¥D­n¬ã¨s­û§Y¬ORuben Mesa.

clinicaltrials.gov/ct2/show/NCT02370329

P1101 in Treating Patients With Myelofibrosis (Phase2 study)

Sponsor: Mayo Clinic

Collaborator: National Cancer Institute (NCI)

Information provided by (Responsible Party): Mayo Clinic

Investigators

Principal Investigator: Ruben Mesa / Mayo Clinic

´Á¶¡: 2015/8¤ë(¶}©l) ~ 2020/3¤ë¡]¹w­p§¹¦¨¡^

¥t¥~, ªþ¤W¤U­±¥h¦~2018 10¤ë/ 12¤ë¤À§O¥Ñ Richard T. Silver »PMD Heinz Gisslinger µoªíªº¨â½g¤å³¹¤¤¤]«ü¥XRopeginterferon ¦bMF À³¥Îªº´Á«Ý¡K (Note: ¥ÑGisslingerµoªíªºMF¤G´Á¤fÀY³ø§i¤£ª¾¬OAOP¼Ú¬w¿W¥ß¶i¦æ©Î¬O©M¬ü°êªº¤G´Á¬ã¨s¬O¤À¶}¶i¦æªº...??)

¤å³¹ #1:

¨Ó·½: www.bloodjournal.org/content/132/Suppl_1/3029

®É¶¡/µoªí³õ¦X: Dec 2018 ASH: (MD Heinz Gisslinger ¤fÀY³ø§iRopeg @ Phase 2 study¦¨ªG)

¼ÐÃD: Effect of Ropeginterferon Alfa-2b in Prefibrotic Primary Myelofibrosis

Blood 2018 132:3029; doi: doi.org/10.1182/blood-2018-99-119268

3029 Effect of Ropeginterferon Alfa-2b in Prefibrotic Primary Myelofibrosis

Program: Oral and Poster Abstracts

¡K¡K¡¦¡¦The fact that no patient showed disease progression in any single parameter after 2 years of treatment (ropeginterferon) can already be considered a success.¡¦¡¦

µ²½×:

In conclusion, the data demonstrate that ¡¥¡¦Ropeginterferon-alfa-2b is able not only to induce hematologic responses but also to improve constitutional symptoms and overall quality of life in prefibrotic PMF¡¦¡¦. Thus ropeginterferon-alfa-2b warrant further investigation as a treatment option in prefibrotic PMF, where only very limited alternatives exist.

¤å³¹ #2

¨Ó·½:

s3-us-west-2.amazonaws.com/eventsquid/Eventsquid/squid2-eventuploads-filename-c36c99b1-d9cb-1d20-a93e9056655d8f3b.pdf

or

www.eventsquid.com/event.cfm?sendToSSL=true&id=3081 (/documents)

®É¶¡/µoªí³õ¦X

11th International Congress on Myeloproliferative Neoplasms, October 25-26, 2018 in New York

¼ÐÃD:

Documents / # Section 4.3:

Debate: Early treatment of MF with IFNs? (Debate: Richard Silver M.D. vs. Ronald Hoffman, M.D.)

Should Patients with ¡§early¡¨ myelofibrosis be treated with interferon?

Interferon is effective in treating the fibrosis that occurs in polycythemia vera in the absence of leukoerythroblastosis. This provided the basis for its use in treating ¡§early¡¨ myelofibrosis

Treatment Implications

1. Early treatment superior to ¡§watchful waiting¡¨. Avoid development of early and advanced MF

2. Consistent with general concept of treating cancer when minimal tumor burden exists

3. Early treatment with rIFN£\ may target both the malignant clone and the chronic inflammatory state in MPN

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´N¦³CML¤G´ÁªºÁ{§É¥ÑAOP¶i¦æ¶i¦æ¤¤

Last Update Posted : March 7, 2019

Estimated Primary Completion Date:September 2021

Estimated Study Completion Date:December 2024

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P1101 in Treating Patients With Myelofibrosis

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Mayo Clinic

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www.targetedonc.com/case-based-peer-perspectives/myeloproliferative-neoplasms/mesa-pv/available-treatment-options-for-patients-with-pv

Available Treatment Options for Patients With PV

Ruben A. Mesa, MD, FACP

Published Online:Apr 22, 2019

Hydroxyurea is a pill. It is simple to take for most. [Its downside is that it¡¦s a nonspecific therapy, and it can lead to neutropenia or thrombocytopenia. It frequently is just not active enough against symptoms, splenomegaly, or other difficulties that people may have. It can increase the risk of cutaneous malignancies. HU¯à¾É­P¤¤©Ê²É²Ó­M´î¤Ö©Î¦å¤pªO´î¤Ö¡C¥¦©¹©¹¹ï¯gª¬¡BµÊ¸~¤j©Î¤H­Ì¥i¯à¦³ªº¨ä¥L§xÃø¤£°÷¬¡ÅD¡C¥¦¥i¥H¼W¥[¥Ö½§´c©Ê¸~½Fªº­·ÀI¡C]

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www.targetedonc.com/news/mesa-discusses-evolving-role-of-interferon-in-mpn-treatment-paradigm

Mesa Discusses Evolving Role of Interferon in MPN Treatment Paradigm

Kristi Rosa

Published Online:3:39 PM, Fri February 22, 2019

Question:

TARGETED ONCOLOGY: What would the clinical implications be if this generation of interferon is approved by the FDA for treatment of patients with MPNs?

ANS:

It would certainly expand their use quite a bit. It would primarily come with less usage of hydroxyurea, which as an older generic drug. It probably wouldn¡¦t change the market that much, but it might lead to a lot of patients switching from hydroxyurea over to interferon.

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Expert Sheds Light on Evolving Role of Interferon in MPNs

Published Online:3:04 PM, Wed April 10, 2019

In an interview with Targeted Oncology, Verstovsek, director of the Hanns A. Pielenz Clinical Research Center for Myeloproliferative Neoplasms at The University of Texas MD Anderson Cancer Center, discussed the use of interferon in MPNs, including essential thrombocythemia (ET), polycythemia vera (PV), and myelofibrosis.

TARGETED ONCOLOGY: What are some potential avenues for future research with interferon?

MD Srdan Verstovsek:

Ropeginterferon is approved in Europe for PV, and we expect an attempted approval in the United States for PV and ET sometime [in 2019]. Myelofibrosis may be another possibility.

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www.mpnresearchfoundation.org/Drug-Reimbursement

Off-label drugs and the compendia

Many MPN patients are struggling to get insurance coverage for their medicine. This is because most treatments prescribed are not United States Food and Drug Administration (FDA) approved for MPNs and are considered ¡¥off-label¡¦ -- meaning they are for indications other than those referenced in the FDA approved label. Hydrea, Pegasys and IntronA are FDA approved drugs, but are not FDA approved for MPNs.

Approximately half of all anticancer drugs are prescribed off-label. Some managed care organizations and private health insurance plans have declined to reimburse the cost of drugs used ¡¥off-label¡¦ to treat cancer on the ground that these uses are ¡§experimental¡¨ or ¡§investigational.¡¨

The Fee-for-Service Medicare program recognizes certain published compendia as authoritative references to identify medically accepted, unlabeled uses of drugs in anticancer treatment regimens. Some insurers refer to compendia when making policy decisions, thus creating a strong financial incentive for manufacturers to obtain a favorable compendium recommendation.

Of the four compendia, only two mention Hydrea for off-label use in Polycythemia Vera and none mention Pegasys which is growing in use among PV patients. Hydrea is typically universally reimbursed for all MPNs due to its compendia listing and relative low cost. This is not the case for Pegasys. Many MPN patients are experiencing insurance denials for Pegasys. Pegasys is a pegylated form of Interferon alpha made by Roche. It is FDA approved for Hepatitis C and as a result of its efficacy and tolerance in MPN phase II studies it is being prescribed more often in treatment for MPNs. While some patients are fortunate to have Pegasys approved upon initial prescription by their physician, many are being denied coverage immediately or after one year of treatment because it¡¦s not FDA approved for MPNs.

Additional information on the history of off-label drug use can be found here.

What does all this mean for MPNs? Some of the more common treatments for MPNs include IntronA, Hydrea and Pegasys. None of these are FDA approved for MPN and thus are being prescribed off-label. The MPN Research Foundation is currently looking into encouraging drug companies to apply for compendia listings

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