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US Polycythemia Vera 2015... 2018E

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www.targetedonc.com/case-based-peer-perspectives/myeloproliferative-neoplasms/mesa-pv-hydroxyurea-intolerant/the-evolving-treatment-landscape-of-polycythemia-vera

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Next, I¡¦m excited about new therapies in the pipeline. Long-acting interferons, of which there¡¦s at least 2¡Xpegylated interferon and ropeginterferon alpha-2a¡Xhave been shown to be at least equivalent to hydroxyurea as upfront therapy. As I¡¦ve shared with patients, ruxolitinib and interferons are good drugs for patients with polycythemia vera. It¡¦s really likely that, in the future, we¡¦ll probably see less use of hydroxyurea and more use of these other agents, which clearly are more active and more effective.

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p50/51 ---CEMPO Treatment Guidelines for PV

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Updates From ASH 2018: The Latest on Interferon Therapy in MPNs

www.patientpower.info/video/updates-from-ash-the-latest-on-interferon-therapy-in-mpns?fbclid=IwAR1LMhZHtIAo4Wkisc_WLdm9cCQYB-zH6Audh7fo27-D9KuaV34cebyEdYU

¦U¦ì¤j¤j¡A³o½g³ø¾É¬O¤zÂZ¯ÀÀ³¥Î©óMPNs±wªÌ¤§³Ì·s»¡©ú¡A¨ä¤¤Dr. Verstovsek¦³¦h³B´£¨ìROPEG¤§ÀuÂI¡A¸`¿ý¦p¤U

¡K..But there is another one I like. It¡¦s called super long-acting. You know, Pegasus has this pegylated part that makes it long acting for a week, we give it weekly. The super long-acting, which is called ropeginterferon, or ropeg for short and is given every two weeks and perhaps even once a month. So if there is any side effect, it would not be obvious because side effects are usually related to injections. You have those flu-like symptoms¡K..

¡K.And in case of the ropeginterferon there are three studies or results of three studies that are being presented here. All these studies unfortunately, or fortunately for patients that can access it in Europe, not done in the United States as of yet. It was a study in long-term outcome patients in the¡Xwith ropeginterferon treated that have a PV, then as you said in early-stage myelofibrosis, prefibrotic myelofibrosis and the last study which is actually oral presentation here is comparison to Hydrea where it appears to be better than hydroxyurea in polycythemia vera¡K¡K

¡K.Hopefully, we will have it in clinical studies, and I encourage everybody to participate, in ET and possibly in PV here in the United States¡K..

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2. 2018/12/11 m.moneydj.com/f1a.aspx?a=0a5f1448-1587-43c1-8524-746bd3cb257a

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·|­û¡GDarren10146466  µoªí®É¶¡:2018/12/11 ¤U¤È 01:26:50²Ä 5421 ½g¦^À³
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¸É¥¿..

·í¤ëMeeting highlights

Four other orphan medicines were recommended for approval by the Committee: Cablivi (caplacizumab) for the treatment of acquired thrombotic thrombocytopenic purpura; Mepsevii (vestronidase alfa) for the treatment of mucopolysaccharidosis type VII; Veyvondi (vonicog alfa) for the treatment of von Willebrand disease and Vyxeos (daunorubicin / cytarabine) for the treatment of acute myeloid leukaemia.

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¤pªº­è¬d¹ï¤@¤U..

CHMPªº¹CÀ¸³W«h¥i¯à¤ñ·Q¹³ªº³æ¯Â..

¥u­n¦bScope:¶µ¥Ø¤º¦³Opinionªº·í¤ëMeeting highlights´N·|§@¥X·N¨£..¬d¹ï6­Ó¤ëµL²§..

¥]§t25-28 June 2018¤¤

2. Oral Explanations

2.1. Pre-authorisation procedure oral explanations

2.1.1. vestronidase alfa - Orphan - EMEA/H/C/004438

Ultragenyx Germany GmbH; treatment of Mucopolysaccharidosis VII (MPS VII; Sly syndrome) for patients of all ages

Scope: Possible oral explanation, Report from the ad-hoc expert group meeting held on 19 June 2018, Opinion

Action: Possible oral explanation to be held on 26 June 2018 at time 16:00 List of Outstanding Issues adopted on 26.04.2018, 22.02.2018.

List of Questions adopted on 14.09.2017. Note: The final list of experts for the ad-hoc expert group meeting held on 19 June 2018 was adopted via written procedure on 18.06.2018 See 3.1

2

·í¤ëMeeting highlights

Four other orphan medicines were recommended for approval by the Committee: Cablivi (caplacizumab) for the treatment of acquired thrombotic thrombocytopenic purpura; <<>> for the treatment of mucopolysaccharidosis type VII; Veyvondi (vonicog alfa) for the treatment of von Willebrand disease and Vyxeos (daunorubicin / cytarabine) for the treatment of acute myeloid leukaemia.

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AOP Orphan Pharmaceuticals AG; treatment of polycythemia vera

Scope: Oral explanation/Opinion

Action: Oral explanation to be held on 11 December 2018 at time 11:00

List of Outstanding Issues adopted on 15.11.2018, 26.07.2018. List of Questions adopted on

22.06.2017.

¬O³o¦¸©Ò¦³¤fÀY³ø§iÃĪ«¤¤°ß¤@¦³¥[µùopinionªºÃĪ«¡A«Ü¥i¯à·|¦b³o¦¸µ¹¥X·N¨£¡C

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CHMP 12¤ë agenda ¥X¨Ó¤F

www.ema.europa.eu/documents/agenda/agenda-chmp-agenda-10-13-december-2018_en.pdf

¦¹¦¸ÁÙ¬O¦C¦b Pre-authorisation procedure oral explanations

¦ýScope¦h¤F Opinion

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ÃĵØÃÄ°õ¦æªøªL°êÄÁªí¥Ü¡AP1101­YÀòEMA³Ì²×¼f¬d³q¹L¨ú±oPVÃÄÃÒ¡A±N¬O¥þ²y²Ä1­Ó³Q®Ö­ã¥Î©óªvÀøPV¯f±wªº¤zÂZ¯À¥B¬°²Ä¤@½u¥ÎÃÄ¡A©¡®É±N¤j´T§ïÅÜÂå®vªº¥ÎÃĤ覡¡A·Rªv½¦Ån¡]Hydroxyurea,HU¡^¥i¯à¤£¦A³Q¨Ï¥Î°µ¬°ªvÀøPVÃĪ«¡A³o¹ïP1101¥¼¨Ó©Ý®i¼Ú¬üPV¥«³õ¨ã¬Û·í¤jªº«ü¼Ð·N¸q¡A¦P®É¦b¨Ï¥Î¶Ç²Î¤zÂZ¯ÀªvÀøPVªº¤¤°ê¤j³°¥«³õ§ó¦³¿EÀy®ÄªG¡C

ªL¸³»¡ªk¬O¤ñ¸û¦Û«H¦Û¤j¨Ç.¦ý¤]¤£µL¥i¯à,²¦³º¤w¦³¥X²{³oºØÁn­µ:Polycythemia Vera: When to Move from Hydroxyurea to Second Line Therapy

www.clinical-lymphoma-myeloma-leukemia.com/article/S2152-2650(17)31307-1/pdf

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¦bP1101¤W¥«¬°²Ä¤@½u¥ÎÃÄ«á,«öRuben Mesa, MD(He is currently the Panel Chair for the National Cancer Center Network (NCCN) MPN Treatment Guideline Panel. )¦a¬Ýªk,¥«¦û²vÀ³¸Ó·|¶W¶V¹LHU!!!

www.targetedonc.com/case-based-peer-perspectives/myeloproliferative-neoplasms/mesa-pv-hydroxyurea-intolerant/the-evolving-treatment-landscape-of-polycythemia-vera

......

Next, I¡¦m excited about new therapies in the pipeline. Long-acting interferons, of which there¡¦s at least 2¡Xpegylated interferon and ropeginterferon alpha-2a¡Xhave been shown to be at least equivalent to hydroxyurea as upfront therapy. As I¡¦ve shared with patients, ruxolitinib and interferons are good drugs for patients with polycythemia vera. It¡¦s really likely that, in the future, we¡¦ll probably see less use of hydroxyurea and more use of these other agents, which clearly are more active and more effective.

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(6446) ÃĵØÂåÃĵoªí Ropeginterferon Alfa-2b Á{§É¸ÕÅç³Ì·s¶i«×

www.asianhhm.com/pressreleases/pharmaessentia-updates-progress-of-ropeginterferon-alfa-2b-clinical-program

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3. ÃĵØÂåÃÄÄ~Äò»P¬ü°ê­¹«~ÃÄ«~ºÊ·þºÞ²z§½(FDA)°Q½×¦p¦ó±Nropeginterferon alfa-2b³Ì¦³®Ä²vªº´£¨Ñµ¹¬ü°êPV¯f±w

4. ÃĵØÂåÃÄ­pµe±Ò°Êropeginterferon alfa-2b¥Î©óªvÀø­ìµo©Ê¦å¤pªO¼W¥Í¯g(ET)ªº¥þ²yÁ{§É¸ÕÅç

# Ropeginterferon alfa-2b¦bªvÀøPV¤è­±«ùÄòÀø®Ä©M¦w¥þ©Ê

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¦³Â²Å餤¤åª©..

药华医药¤½¥¬Ropeginterferon Alfa-2b临§É项¥Ø³Ì·s进®i

www.prnasia.com/story/231644-1.shtml

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·|­û¡G°e³øªº10135990  µoªí®É¶¡:2018/12/6 ¤W¤È 09:35:30²Ä 5401 ½g¦^À³
PharmaEssentia Updates Progress of Ropeginterferon Alfa-2b Clinical Program

Wednesday, December 05, 2018

WALTHAM, Mass., Dec. 5, 2018 /PRNewswire/ --

•36 month analysis of ropeginterferon alfa-2b (Ropeg) phase III clinical data in Polycythemia Vera (PV) demonstrates superiority across three key aspects of disease control, including complete hematological response (CHR), disease burden, and molecular response

•A long-term development partner of Ropeg, AOP Orphan¡¦s submission for marketing authorization of ropeginterferon alfa-2b in the EU is in the final stage of European Medicines Agency (EMA) regulatory review

•PharmaEssentia is continuing to discuss with the US Food and Drug Administration (FDA) the best path forward to make ropeginterferon alfa-2b available to PV patients in the US

•PharmaEssentia is planning to initiate a global clinical development program of ropeginterferon alfa-2b in Essential Thrombocythemia (ET)

www.asianhhm.com/pressreleases/pharmaessentia-updates-progress-of-ropeginterferon-alfa-2b-clinical-program

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www.aoporphan.com/news-media/press-release/aop-newscenter-detail-page/artikel/aop-orphan-announces-three-year-results-on-ropeginterferon-alfa-2b-in-polycythemia-vera-at-the-american-society-of-hematology-ash-annual-meeting-2018.html

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Committee for Orphan Medicinal Products (COMP)

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lanadelumab ¡V EMEA/H/C/004806

Action: For discussion

9 ¤ë

lanadelumab ¡V EMEA/H/C/004806

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mexiletine hcl ¡V EMEA/H/C/004584

Action: For discussion

10 ¤ë

lanadelumab ¡V EMEA/H/C/004806

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mexiletine hcl ¡V EMEA/H/C/4584

Action: For adoption

Committee for medicinal products for human use (CHMP)

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initial applications; opinions

lanadelumab ¡V EMEA/H/C/004806

mexiletine hcl ¡V EMEA/H/C/004584

Meeting highlights from the Committee for Medicinal Products for Human Use October 2018

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recommended for approval, including two orphan medicines

lanadelumab

mexiletine hydrochloride

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4.2.2. - ropeginterferon alfa-2b - EMA/OD/055/11, EU/3/11/932, EMEA/H/C/004128

AOP Orphan Pharmaceuticals AG; Treatment of polycythaemia vera

Action: For discussion

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4.2.2. - ropeginterferon alfa-2b - EMA/OD/055/11, EU/3/11/932, EMEA/H/C/004128

AOP Orphan Pharmaceuticals AG; Treatment of polycythaemia vera

Action: For adoption, Oral explanation to be held on 5 December 2018 at 10:00

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Committee for Orphan Medicinal Products (COMP) Draft agenda for the meeting on 04-06 December 2018

Review of orphan designation for orphan medicinal products at time of initial marketing authorisation

Orphan designated products for discussion prior to adoption of CHMP opinion

ropeginterferon alfa-2b

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4.2.2. - ropeginterferon alfa-2b - EMA/OD/055/11, EU/3/11/932, EMEA/H/C/004128

AOP Orphan Pharmaceuticals AG; Treatment of polycythaemia vera

Action: For adoption, Oral explanation to be held on 5 December 2018 at 10:00

Document(s) tabled:

Draft report on review of OMPD

4.2.2¡C - ropeginterferon alfa-2b - EMA / OD / 055/11¡AEU / 3/11 / 932¡AEMEA / H / C / 004128

AOP Orphan Pharmaceuticals AG; ªvÀø¬õ²Ó­M¼W¦h¯g

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www.ema.europa.eu/documents/agenda/agenda-comp-agenda-4-6-december-2018-meeting_en.pdf

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COMP 11¤ëªºmeeting report ¥X¨Ó¤F, ¨S´£¨ìRopeg?!

www.ema.europa.eu/documents/committee-report/comp-meeting-report-review-applications-orphan-designation-november-2018_en.pdf

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·|­û¡GAlan Liu10136094  µoªí®É¶¡:2018/11/30 ¤W¤È 12:57:01²Ä 5378 ½g¦^À³
¥H¤U¬°Blood Journal 2018 µoªí P1101®¦·OÀøªk¨ú¥N¥ý«e¨Ï¥ÎPegasys¶i¦æªvÀøªº°ª­·ÀIPV/ET¯f±w, ½Ķ¦p¤U¨Ñ¦U¦ì§ë¸ê¥ý¶i­Ì°Ñ¦Ò, ÁÂÁ¡C

Compassionate Use of Ropeginterferon-Alfa-2b/P1101 for Treatment of High Risk Polycythemia Vera and Essential Thrombocythemia Patients Previously Controlled on Pegylated Interferon-Alfa-2a/Pegasys®

Ropeginterferon-Alfa-2b/ P1101®¦·OÀøªk¨ú¥N¥ý«e¨Ï¥ÎPegasys¶i¦æªvÀøªº°ª­·ÀIPV/ET¯f±w

www.bloodjournal.org/content/132/Suppl_1/5459

Blood 2018

2018¦~¦å²G´Á¥Z

Abstract

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Polycythemia vera (PV) and essential thrombocythemia (ET) are chronic myeloproliferative neoplasms (MPN) associated with morbidity and mortality resulting from thrombosis or transformation to myelofibrosis and/or secondary acute leukemia. The acquired somatic mutation JAK2V617Fhas been observed in 98% of PV patients, and around 50% of ET patients. Interferon is known to be an effective treatment for chronic MPNs, but unlike hydroxyurea (HU, Hydrea®), it has been shown to target the malignant clone by decreasing JAK2V617Fallelic burden, and in some patients restoring polyclonal hematopoiesis. (Liu et al, Blood. 2003;101:3294-3301). The covalent binding of polyethylene glycol to the interferon molecule, through pegylation, prolongs the half-life by lowering the clearance of interferon, thereby extending the duration of its therapeutic effects, permitting less frequent administration and fewer side-effects. Currently, there are two commercially available pegylated interferons in the U.S., peginterferon alfa-2b (PEG-Intron®, Merck) and peginterferon alfa-2a (Pegasys®, PEG, Roche), both with heterogeneous pegylation with multiple pegylation sites. Ropeginterferon-alfa 2b/P1101 (ROPEG) is a novel longer acting mono-pegylated recombinant proline-interferon alfa-2b which has shown good efficacy in PV and has successfully completed a phase III trial in PV patients comparing it against HU (PROUD-PV study) in Europe (ASH2016 Abstract;Blood. 2016;128:475).

PV©MET¬OºC©Ê°©Åè¼W¥Í©Ê¸~½F¡]MPN¡^¡A¥Ñ¦å®ê´c¤Æ¦¨°©ÅèÅÖºû¤Æ©M/©ÎÄ~µo©Ê«æ©Ê¥Õ¦å¯fµo¯f²v©M¦º¤`²v¬ÛÃö¡C98¢HªºPV¯f±w©M¬ù50¢HªºET¯f±w¤¤Æ[¹î¨ì¬ðÅܲӭMJAK2V617F¡C¤zÂZ¯À¬OºC©Ê°©Åè¼W¥Í©Ê¸~½F¡]MPN¡^ªº¦³®ÄªvÀø¤èªk¡A©MHU¤£¦Pªº¬O¡A¤zÂZ¯À³q¹L¹v¦V´c©Ê§J¶©­°§C JAK2V617Fµ¥¦ì°ò¦]­t¾á¡A¨Ã¥B¦b¬Y¨Ç¯f±w¤¤«ì´_¦h§J¶©³y¦å§@¥Î¡C

³q¹LPEG§Þ³N±N»E¤A¤G¾J»P¤zÂZ¯À¤À¤lªº¦@»ùµ²¦X¨Ó©µªø¥b°I´Á¡A±q¦Ó©µªø¨äªvÀø®ÄªGªº«ùÄò¡A¤¹³\¸û§CÀW²vªºª`®g©M¸û§Cªº°Æ§@¥Î¡C¥Ø«e¡A¦b¬ü°ê¦³¨âºØ°Ó·~¤Æªºªø®Ä«¬¤zÂZ¯À¡A§YÀq§JªºPEG-Intron©Mù¤óªºPegasys¡A¨âªÌ§¡¨ã¦³¨ã¦³¦h­Ó¦P¤À²§ºcª«¡C Ropeginterferon-alfa 2b / P1101¡]ROPEG¡^¬O·s¤@¥Nªø®Ä«¬¤zÂZ¯À£\-2b¡A¦bPV¾AÀ³¯g¤¤Åã¥Ü¥X¨}¦nªºÀø®Ä¡A¨Ã¦b¼Ú¬w¦¨¥\§¹¦¨¤F»PHU¶i¦æ¤ñ¸ûªºPVÁ{§É¤T´Á¸ÕÅç¡C

Earlier, we had enrolled 53 high risk PV and ET patients to the Myeloproliferative Disorders Research Consortium (MPD-RC) trials #111 (refractory to HU) and #112 (randomized to HU vs PEG)(www.clinicaltrials.gov; NCT01259856 and NCT01259817). After the completion of these trials, PEG was no longer supplied by the study and not adequately covered by insurance for many of our patients. Therefore, ROPEG was procured under an FDA-approved expanded access program and used as a substitute for those controlled on PEG, and these patients are being transitioned from PEG to ROPEG according to the dosing strategy shown in Table 1.

§Ú­Ì¥ý«e¤w±N53¦W°ª­·ÀIPV©MET¯f±w¯Ç¤J°©Åè¼W¥Í©Ê¯e¯f¬ã¨sÁp·ù¡]MPD-RC¡^¸ÕÅç¡­111¡]¹ïHUµL®Ä¡^©M¡­112¡]ÀH¾÷¤À°t¦ÜHU ©Mªø®Ä«¬ PEG¡^¡Cªø®Ä«¬¤zÂZ¯À¦b¸ÕÅ秹¦¨«á¤£¦A´£¨Ñ¡A¦Ó§Ú­Ìªº³\¦h¯f±w¨Ã¨S¦³«OÀI§¹¾ã«O»Ù¡C¦]¦¹P1101¦bFDA§å­ã«á¨ú¥Nªø®Ä«¬¤zÂZ¯À¡A³o¨Ç¯f±w®Ú¾Úªí1©Ò¥Üªº¾¯¶qµ¦²¤±qªø®Ä«¬¤zÂZ¯ÀÂàÅܬ°ROPEG (P1101)¡C

Seven patients have been switched onto ROPEG as of writing this abstract (Table 2). After a mean follow-up of roughly 8 weeks (range: 2 - 10 weeks), all have maintained response to therapy and none have had a thrombotic event or new or increased interferon-related side effects thus far. Patient 002 experienced elevated AST/ALT while on PEG, which normalized after four q2 week doses of ROPEG (8 weeks of therapy). Patients 003 and 004 who had persistent fatigue on PEG, saw significant improvement of their symptoms after switching to ROPEG. In patient 005 who has ET, bone marrow cytogenetics at entry to PEG had a paracentric inversion of the long arm of chromosome 3, namely 3q21.3q26.2 (RPN1/MECOM, inv3; diagnostic of AML per WHO criteria), in 16/20 (80%) metaphases. Over the 4 ensuing years while on PEG, this cytogenetic abnormality progressively decreased. FISH assay was set up 2 years ago wherein 86/200 cells (46%) were positive with lowest achieved level of 36/200 cells (18%) without any evidence of emerging AML. Upon transition to ROPEG (2 fortnightly injections of 50 mcg), this response was maintained (23/200 cells scored (11.5%). Of the 3 patients who were JAK2V617Fpositive, one patient (patient 003) showed a decrease in the JAK2V617Fallelic burden (37% to 18%) after two months of ROPEG despite decreasing the dose to 50 mcg (from 100 mcg) 2 weeks after the first injection, while the other two patients had no statistically significant change in their JAK2V617Fallelic burden. Clonality will be followed in female subjects to see if clonal hematopoiesis is suppressed and normalizes with long-term administration of ROPEG.

¦b½s¿è¥»½gºK­n®É¡A¤w¦³7¦W±wªÌÂà¤JROPEG¡]ªí2¡^¡C¦b¥­§¡¤¤¦ì¼Æ¤j¬ù8¶g¡]½d³ò¡G2-10¶g¡^ªº°lÂÜ«á¡A©Ò¦³¤H³£«ùÄò¹ïªvÀøªºÀø®Ä¤ÏÀ³¡A¨Ã¥B¨´¤µ¬°¤î¨S¦³¦å®ê¨Æ¥óµo¥Í©Î·s¼W¥[ªº¤zÂZ¯À¬ÛÃö°Æ§@¥Î¡C¯f±w002¦bªø®Ä«¬¤zÂZ¯À®ÉAST / ALT¼Æ¦r¼W¥[¡A¦ý¦b4¦¸P1101Àøµ{«á¡]ªvÀø8¶g¡^¥¿±`¤Æ¡C¯f±w003©M004­ì¥»¦³«ùÄò¯h³Òªº¯gª¬¦bÂà´«¦¨P1101«á¯gª¬©úÅã§ïµ½¡C¯f±w005¬°ET¯f±w¡A¦bªø®Ä«¬¤zÂZ¯ÀªºÀøµ{¤U¡A°©Åè²Ó­M¿ò¶Ç¾Ç¨ã¦³3¸¹¬V¦âÅ骺²§±`¡A¦bÀH«áªº4¦~¨Ï¥Îªø®Ä«¬¤zÂZ¯ÀªvÀø«á³oºØ²Ó­M¿ò¶Ç¾Ç²§±`³vº¥´î¤Ö¡C²Ó­M¿ò¶Ç¾ÇFISHÀË´ú©ó2¦~«e¶}©l¡A¨ä¤¤86/200²Ó­M¡]46¢H¡^¬°¶§©Ê¡A36/200²Ó­M¹F¨ì³Ì§C¤ô¥­¡]18¢H¡^¡A¨S¦³¥ô¦ó·s¥X²{ªºAMLÃÒ¾Ú¡CÂà´«¬°ROPEG¡]¨C2¶gª`®g¤@¦¸50 mcg¡^«á¡A¤ÏÀ³«ùÄòºû«ù¡]23/200¡Aµû¤À¡]11.5¢H¡^¡C

¦b3¦WJAK2V617F§e²{¶§©Ê¯f±w¤¤¡A1¦W¯f±w¡]±wªÌ003¡^JAK2V617F µ¥¦ì°ò¦]­t¾á´î¤Ö¡]¾¨ºÞ¦b²Ä¤@¦¸ª`®g«á±N¾¯¶q±q100mcg´î¤Ö¦Ü50 mcg¡A¦ýµ¥¦ì°ò¦]­t¾á±q37¢H´î¤Ö¦Ü18¢H¡^¡A¦Ó¥t¥~¨â¦W¯f±wªºJAK2V617Fµ¥¦ì°ò¦]­t¾á¨S¦³²Î­p¾Ç¤WªºÅãµÛÅܤơC¤k©Ê¨ü¸ÕªÌ³z¹Lªø´ÁªºP1101ªvÀøÆ[¹î§J¶©©Ê³y¦å¬O§_³Q§í¨î¨Ã¥B¥¿±`¤Æ¡C

Our early experience suggests ROPEG is a safe and effective alternative to PEGpermitting less frequent administration for patients with high risk PV and ET. Notable observations include normalization of hepatic transaminases previously induced by PEG, maintenance or even suppression of one highly deleterious cytogenetic abnormality, maintenance of ET & PV remission, and amelioration of interferon side-effects with lower equivalent doses. In the future, we intend to increase the pool of patients by designing a protocol for newly diagnosed high risk ET and PV with randomization to HU versus ROPEG.

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­È±oª`·NªºÆ[¹î¥]¬A¥ý«e¦]ªø®Ä«¬¤zÂZ¯À»¤¾Éªº¨x«ü¼Æ¥¿±`¤Æ¡B§í¨î²Ó­M¿ò¶Ç¾Ç²§±`¡BET©MPV¯gª¬½w¸Ñ¡A¥H¤Î¸û§C¾¯¶q§ïµ½¤zÂZ¯À°Æ§@¥Î¡C¥¼¨Ó¡A§Ú­Ì¥´ºâ³]­p·s¶EÂ_ªº°ª­·ÀIET©MPVªº¤è®×Á{§É¸ÕÅç¨Ó¼W¥[¯f±w¸s¡A¨ÃÀH¾÷¤À°t¨ìHU©ÎP1101²Õ¡C

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¥t¤@½gÃö©óRopeginterferon-alfa-2b ·sªºPaper

Novel Therapeutic Approaches in Polycythemia Vera--Clinical Advances in Hematology & Oncology

November 2018 - Volume 16, Issue 11

www.hematologyandoncology.net/archives/november-2018/novel-therapeutic-approaches-in-polycythemia-vera/

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www.aetna.com/cpb/medical/data/400_499/0404.html

¬ü°ê¦w®õ¤H¹Ø°w¹ïinterferon ¾AÀ³¯gµ¹¥I¬ÛÃö»¡©ú¡A¾AÀ³¯g¦h¨ì¤@­Ó¸Ø±i

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Interferon alpha 2a and 2b Aetna considers interferon alpha 2a and 2b medically necessary for the following indications:

1. AIDS-associated Kaposi¡¦s sarcoma;

2. Carcinoid syndrome;

3. Chronic myelogenous leukemia;

4. Condylomata acuminata (genital warts) (intralesional only);

5. Cutaneous T-cell lymphoma (including mycosis fungoides);

6. Desmoid tumors (fibromatosis)

7. Essential thrombocythemia;

8. Giant cell tumor of bone;

9. Hairy cell leukemia, relapsed or refractory;

10. Hepatitis C (non-A, non-B hepatitis).

11. Hyper-eosinophilic syndrome that is not adequately responsive to glucocorticoids;

12. Kasabach-Merritt syndrome;

13. Leptomeningeal metastases of CNS tumors, intracerebrospinal fluid treatment;

14. Life-threatening hemangioma of infancy

15. Malignant melanoma;

16. Meningioma, recurrent, surgically inaccesible;

17. Multiple myeloma, solitary plasmacytoma, or systemic light chain amyloidosis;

18. Neuroendocrine tumors of the GI tract, lung and thymus;

19. Non-Hodgkin¡¦s lymphoma (including adult T-cell leukemia/lymphoma (chronic, smoldering or acute), mycosis fungoides/Sezary syndrome) and primary cutaneous anaplastic large cell lymphoma (ALCL) with multifocal lesions);

20. Ocular herpes simplex

**** 22. Persons with polycythemia vera who meet all of the following criteria: *****

a. Oral therapy with hydroxyurea or other myelosuppressive agent is not effective, not tolerated, or is contraindicated; and

b. Phlebotomy is not effective, not tolerated, or contraindicated.

Note: Failure of phlebotomy and/or myelosuppressive agents may be defined as any of the following:

Lack of hematological control (e.g., hematocrit greater than 45 or platelet count greater than

600 x 10(9)/L);

Occurrence of intractable symptoms (e.g., headaches, pruritis); Occurrence of symptoms related to hepatosplenomegaly; Occurrence of thrombotic or hemorrhagic complications; or

Phlebotomy required more often than once every 2 months

23. Renal cell carcinoma;

24. Respiratory papillomatosis

25. Vulvar vestibulitis

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1. ¨Ì¾ÚEMA¶°¤¤¼f¬dµ{§Ç¡Aoral explanation§¹¦¨«á¶}©l±µÄòD181ªº®Éµ{­pºâ¡A¦]¦¹­ì­q´N¬O12¤ë¤~·|¦³D210 opinion¨Mij¡C

D180 If an oral explanation is needed, the clock is stopped to allow the Applicant to prepare

the oral explanation.

D181 Restart of the clock with submission of responses or oral explanation (if needed).

2. Ropeg¥Ó½Ðªº¾AÀ³¯g´N¬OPV¡A¦b¨ä¥LET,MF¾AÀ³¯gÁö¦³¼ç¤O¡A¦ý©|¥¼¶i¤Jpivotal¸ÕÅç¡A¤]¤£·|¦³©Ò¿×©x¤è¥D­nµ¹¤©¼W¥[¾AÀ³¯gªº¥i¯à©Ê¡A¤Á¤Å°µ¹L«×¤£¤Á¹ê»Úªº·Q¹³¡C­YRopeg¦bD210¶¶§Q¨ú±o¥¿­±·N¨£¡A«áÄò­nÃöª`ªº¬O¡ARopeg¦bPV¤@½uÃÄÃÒ©Ò¾A¥Îªº¥Ø¼Ð±Ú¸s½d³ò¡C

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­Ó¤H»{¬°ÃĵØÃĦb®Ö­ã«e¡A¬°¤°»òÁÙ­n¨Ó­Ó¤f¸Õ¡A¤§«e§Ú¤]´¿»¡¹L¤½¥q¨º®É¥¿·Ç³Æªº¬O¦^ÂФ@¨Ç­«­n¼Æ¾Ú¤è­±¡]²{¤w¸g¦^ÂФF¡^¡C¤½¥q¤è­±ªºÃĮĿ@«×µ¥¤§©Ò¥H¯à¶W¥X·~¬É¡A¬O¦]¬°¦³Àu©ó·~¬Éªº»sµ{¡A¦Ó¤½¥q¦ÑÁó¤]´¿»¡¹L¡A¼Ú·ù©x­û¹ï¦¹»sµ{¤£¬O«Ü¤F¸Ñ¡C©Ò¥H­Ó¤H»{¬°¦p¦ó¯à«O¦¹ÃĮī~½è¡A¬O¼Ú·ù¼f¬dªº­«ÂI¡A©Î³\¦¹¦¸¤fÀY»¡©úÀ³·í¸ò³o­Ó¦³Ãö§a¡C¥t¤@¤è­±¡A­Ó¤H±ÀºV©Î³\¸ò¥é³æ¦³Ãö¡A¦]¬°¦¹ÃIJ{¦b¥i¯à¹ï§ó¦h¤è­±ªºªvÀø³£¤£¿ù¡C

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¦p¦P¤W­z½Ñ¤j±M®a¬Ýªk, ±Æ¤J12¤ë¥÷CHMP agenda À³¸ÓÄÝ©ó¦X²z¡K­Ó¤H±ÀºV²L¨£¦p¤U:

¤½¥qÀ³¸Ó¦bD180 outstanding issue ¦Ó¦b¥»¦¸Nov. CHMP meeting¤§«á,·Ç³Æ¨B¤J¤U­Ó¤ëªº D210/D215...

1.°O±o¥»½×¾Â¦³¼ö¤ßªº¤j¤j¦b9¤ë¥÷´£¨ìEMA§Æ±æ¼f®Ö±M®a¤]°Q½×¤½¥q¥é³æªºÄ³ÃD¡K.¦Ó¥»¤H©ó10¤ë¤¤¦¯°Ý¤½¥q¥Ø«e¨s³º¦b¤°»ò¶¥¬q? ¥D­n°ÝÃD¬°¦ó? ·í®Éµo¨¥¤H»¡:¡u¥Ø«e¦bD180 outstanding issue¶¥¬q, LoQ¤w¦^ÂÐ, ¥Ø«e¥D­n³Ñ¤U¥é³æ¬ÛÃöªº¦^ÂСK..¡v ®É§Ç¶i¤J¨ì11¤ë, ²×©óµØ¤Í­Ì¬ß¨ì¤FRopeg³Q±Æ¨ì11/6-8 COMP meeting,¡K¤Î 11/12-15 CHMP meeting ªºPre- authorisation oral explanations.

2.µM¦Ó¡K·Q·Q¬Ý, 5/25 ´£¥XD120 LoQ°ÝÃD²M³æ®É, ·Ó®É§Ç¤ÀªR 5/26´N¬OD121...¬°¦ó¤@ª½¨ì11¤ë¤~±Æ¤JCOMP & CHMP pre-authorization, oral explanation? ­Ó¤H±ÀºV, ¤½¥q¦b·Ç³Æ D180 LoQ ¦^ÂЮɴX¥G¥Î¼f®Ö³æ¦ì¤¹³\³Ìªøªº´Á­­ (3­Ó¤ë) ©Î³\¬O¬°ª§¨úÁ{§É§ó¦h¦³§Q¼Æ¾Ú¾ã²z, ¾ã¦X±M®a·N¨£¥H¤Î»P«á­±ªº²£«~µ¦²¤§ñÃö (i.e¥é³æ»P¥é³æ¼Ð¥Ü¥~ªº¾AÀ³½d³ò»P²Ó¸`§ñÃö) ==> ²z¥Ñ: °O¤£°O±o¤½¥q¦b11/2¤½§iµ¦²¤¹Ù¦ñAOP±N©ó ASH USA 2018 12/1~4 µoªí¤T½g¦³ÃöRopeginterferon Alfa-2b¡]P1101¡^¤§³ø§i, ¨ä¤¤²Ä¤T½g´£¨ìRopeginterferon Alfa-2b¥Î©óªvÀø­ìµo©Ê°©ÅèÅÖºû¤Æ (PMF)¤§®ÄªG; ²Ä¤@½gµ²½×´£¨ì: ¡¥¡¦The effect not only on JAK2V617F but other mutations involved in MPNs and on ‎²Ó­M¾Ç‎ ‎·îÅÜ‎ confirm the concept of disease modification capability of IFNa. Ropeginterferon alfa-2b will provide a valuable and safe new long-term treatment option with features distinct from other treatment modalities including HU¡¦¡¦ (µù: Ropeginterferon ªºÁ{§É³]­p¥D­n°w¹ïªº¬OPV; P1101 Pipeline for ET ¦bphase3, ¦ý¬OPMF­ìµo©Ê°©ÅèÅÖºû¤Æ¨Ã¤£¦b¤½¥qP1101 ªºpipeline¤¤; µM¦Ó ±qAOP/Ãĵتñ´Á¶i¤@¨Bªº¤ÀªR¸ê®Æ·Pı, ¡¦¡¦§í¨îJAK2°ò¦]ªº¬ðÅÜfor PV and other MPN (ex PMF)¬O¨ä¯S¦â, AOP/¤½¥q¥i¯à¦b«ä¦Ò¦p¦ó¶i¤@¨BÂX¤j²£«~¾AÀ³½d³ò§a!

3.¥»¦¸11/12-15 CHMP meeting agenda °w¹ïRopeginterferon, ¤j®a¥i¥H¦^¥h¬Ý¬Ýmeeting agenda°w¹ï¨C­ÓÃĪº scope and action

==> Ropeg ªºScope¼g¨ì: Oral explanation & SAG (Scientific Advisory Groups) report (¬Û¸û©ó¦P¶¥¬qpre-authorisation and oral explanationsªº¥t¨â­ÓÃĪºromosozumab ¤Î volanesorsen ªºScope³£¨S¦³»Ý­nSAG report). ¬O¬G, ±À´úRopegÃĪº¥é³æ¤º¥~²Ó¸`¥i¯à¼vÅT½d³ò¤j, ¦³¥²­nÅýSAG¬ì¾Ç¿Ô¸ß¹ÎÅé¤]°Ñ»P¨ó§U»PÂç²M¼f®Ö³æ¦ìªº°ÝÃD, ¬O¬G¦b¥»¦¸ªº¤fÀY³ø§i·|ij¤¤ SAG report is included/involved)

4.­Y«ö·Ó¤W­z¤ÀªR, ÁöµM¥»¤H¤Î²³µØ¤Í­Ì¹ï11/12~15meeting highlight©ê°ª«×´Á±æ, ¦ý¬O©|¥¼¥X²{Ropeginterferon ªºµû¦ôµ²½×¦ü¥G¤]¥i²z¸Ñ! ¥BÅý·R¦nµØ¤ÍªÌ¦@¦PÀR¤ßµ¥«Ý¡K¡K¡K«E«Ý³Q±Æ¤W 12/10~13meeting agenda and it¡¦s final glory!

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§Ú­Ó¤H¦b²q·Q¡ACHMP¥²¶·µ¥COMPªº11/6-11/8ªº·|ijµ²½×¥¿¦¡½T»{¡A¤~·|±Nropeg¦C¤Jµ¹¤©·N¨£ªºÄ³µ{¡C

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CHMPªº11¤ë·|ij¦P¨B¥ýÅ¥AOPªì¨B¤fÀY³ø§i¡Aµ¥COMP·|ijµ{§Ç§¹³Æ½T»{«á¡A¦A¥æ¥ÑCHMP©ó12·|ij¼f¡C

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¥H¤µ¦~¦Ü¤µ¡A¦³¦h¤ÖªºÃÄ«~«e¤@¤ë¦C¤JPre-authorisation procedure oral explanationsijµ{ ¡A¹j¤ë´N³Q¦C¤Jinitail application:opinionsijµ{ªº¤ñ²v¦³¦h¤Ö¡H¦Ó³o¨Ç¤½¥q¦b³Q¦C¤Jinitail application:opinionsijµ{·í¤ë§YÀò±o¥¿­±·N¨£ªº¦³¦h¤Ö¡H¤Ï­±·N¨£ªº¦³¦h¤Ö¡H

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New version of EMA¡¦s pre-authorisation procedural advice for the centralised procedure released

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¤E¤ë¦³¤@°¦ Pre-authorisation procedure oral explanations

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