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2017 Top 20 Blockbuster Cancer Drugs www.thebalance.com/top-cancer-drugs-2663234

18). Jakafi Manufacturer: Incyte/Novartis Condition or Diseases treated: Polycythemia vera; myelofibrosis​

Global sales: $1.434 billion Generic name: Ruxolitinib (PV¤G½uÃĪ«)

19).Tarceva Manufacturer: Roche Condition or Diseases treated: Non-small-cell lung, pancreatic cancers

Global Sales: $1.428 billion Generic name: Erlotinib (¯ØŦÀù¤@½uÃĪ«)

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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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¦bRopeginterferon ¨ú±o¼Ú¬wÃÄÃÒ«á, Ä~ MD Mesa, Srdan Verstovsekµû½×¤§«á, ²Ä¤T¦ìKOL MD Richard Silver

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He said:...

In our clinic, we don¡¦t believe in the watch and wait approach that is recommended by some [physicians] because it develops iron deficiency in patients

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

We also have evidence that interferon will reduce JAK2, the genetic abnormality that characterizes PV

¦Ü©ó¥¼¨ÓJakafiªº¤è¦V....

Ruxolitinib (Jakafi) is very helpful in these patients, but I don¡¦t believe it definitively changes the disease from the standpoint of bone marrow remission.

I believe it should be used in combination with interferon for the treatment of PV.

#1

www.onclive.com/publications/Milestones-in-Medicine/2019/history-and-evolving-role-of-interferon-in-myeloproliferative-neoplasms/mesa-explores-role-of-interferon-in-evolving-mpn-treatment-paradigm/

Dr Mesa Explores Role of Interferon in Evolving MPN Treatment Paradigm

Kristi Rosa

Published: Wednesday, Feb 20, 2019

#2

www.onclive.com/publications/Milestones-in-Medicine/2019/history-and-evolving-role-of-interferon-in-myeloproliferative-neoplasms/expert-discusses-evolution-impact-of-interferon-in-mpns/

Expert Discusses Evolution, Impact of Interferon in MPNs

Caroline Seymour

Published: Thursday, Feb 21, 2019

Srdan Verstovsek, MD, PhD

#3

Dr. Richard Silver

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?p=2

MPNs Pioneer Highlights Long-Lasting Role of Interferon

Brandon Scalea

Published: Thursday, Feb 21, 2019

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Expert Discusses Evolution, Impact of Interferon in MPNs

³o¬OUS¥t¤@­Ó±M®aSrdan Verstovsek, MD, PhDªº¬Ýªk¡A¸`¿ý­«ÂI¦p¤U¡C

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Ropeginterferon was recently approved in Europe; the announcement was made in December 2018 for the treatment of patients with PV. We hope that we will have that particular medication here in the United States,in clinical studies, in the very near future.

Ropeginterferon has a different chemistry. The pegylated form is different, so it can be given every 2 weeks.After 1 year of therapy, most people in the clinical study were switched over to monthly injections; that isbecause of a chemical property [within] the pegylated part of the construct of the medication. That leads toeasier delivery to patients and decreased frequency, thereby increasing tolerability. The long-term toxicitieson the liver, for example, might be positively affected by decreasing the frequency of the injections.

The real advantage [was seen in] the European study that compared ropeginterferon with hydroxyurea. In this study, the super long-acting interferon was given every 2 weeks and then once a month after longer exposure to an every-2-weeks schedule. Three-year follow-up data were presented from that study and showed clear evidence demonstrating the superiority of interferon to hydroxyurea. The tolerance rate was very good; the dropout rate was low. There was a decrease in the molecular clone or abnormality in patients who were exposed to ropeginterferon from the beginning of the study. At the beginning of the study, hydroxyurea was more effective because it works faster. As hydroxyurea lost its benefit, interferon picked up. Based on these follow-up data, interferon appears to be better both in terms of clinically relevant findings as well as in biological correlates.

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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Dr. Mesa ¨¥½×³£ÆZ¤ä«ùJAkafi,...¥»½g¤]¬O, ¦ý³o¬q¬Ý¬Ý¥L«ç»ò¬Ý(Ropeg)interferon over HU ªº¥¼¨Ó.....

Mesa Explores Role of Interferon in Evolving MPN Treatment Paradigm

Kristi Rosa

Published: Wednesday, Feb 20, 2019

www.onclive.com/publications/Milestones-in-Medicine/2019/history-and-evolving-role-of-interferon-in-myeloproliferative-neoplasms/mesa-explores-role-of-interferon-in-evolving-mpn-treatment-paradigm

Q:

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

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.

but it might lead to a lot of patients switching from hydroxyurea over to interferon.

but it might lead to a lot of patients switching from hydroxyurea over to interferon.

but it might lead to a lot of patients switching from hydroxyurea over to interferon.

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·|­û¡G¤p¥¿¥¿10141351  µoªí®É¶¡:2019/2/20 ¤U¤È 10:07:55²Ä 6004 ½g¦^À³
AOP Orphan announces EU Marketing Authorization for BESREMi® (Ropeginterferon alfa-2b) for rare blood cancer (PV)

BESREMi® is approved as first-line monotherapy in adults for the treatment of Polycythaemia vera (PV) without symptomatic splenomegaly

BESREMi® showed high and durable hematologic response, molecular response and disease modifying capabilities without leukemogenic or carcinogenic potential,

BESREMi® was safe, well tolerated and will be available as a pen for self-administration for patient convenience

Vienna, 20th of February 2019: AOP Orphan Pharmaceuticals AG (AOP Orphan), a European pioneer in rare disease, announced today that the European Commission (EC) has granted Marketing Authorization for BESREMi® (Ropeginterferon alfa-2b) as first line monotherapy in adults for the treatment of Polycythaemia Vera (PV) without symptomatic splenomegaly.

BESREMi® is now approved for use in all twenty-eight-member states of the European Union, as well as in Iceland, Liechtenstein and Norway.

The EC approval was based on data generated in the clinical development program, comprising of pivotal PROUD-PV, PEN-PV, PEGINVERA and the ongoing trial CONTINUATION-PV. Clinical study data on patients receiving treatment up to seven years are available underlining the long experience with BESREMi® in PV.

¡§BESREMi® is the first approved interferon in PV and now, our next goal is to make it available to patients living with this condition in Europe as soon as possible,¡¨ said Andreas Steiner, Chief Executive Officer of AOP Orphan.

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¤@¡BÃĵØÃÄ¥»¤é¨«¶Õ¤£¦p¹w´Á¡AªÑ²¼­nÁÈ¿ú«o¬O¤£®e©ö¡A¥i¯à­n´£¿ô¦Û¤w­±¹ï¥«³õ©l²×­n«O«ùÁ¾¨õ¡C

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1.2014/01/06¡G¤u°Ó®É³ø¡G¼Ú·ùÁ{§É¤T´Á¼Æ¾Ú¥¿­±¡A°ò©ó°ê»ÚÁ{§ÉICHªº­ì«h¡A¥[¤W¥þ²y¯ÊÃÄ¡A¬ü°êFDAªì¨B¦Ò¶q±N¦@¥Î¼Ú·ù¼Æ¾Ú¡AÅýP1101¥i§K°µ¤T´ÁÁ{§É¡C

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I understand the FDA doesn¡¦t normally accept European clinical trial results and that trials would need to be carried out in the states, anyone aware of such trials?

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the decision of the ECJ is expected at the end of February and early March(2¤ë©³3¤ëªì) (67 days after the CHMP opinion is made public).

otszonline.hu/cikk/pozitiv_velemenyt_kapott_a_polycythaemia_vera_elleni_besremi

He received a positive opinion on polycythemia vera Besrem

February 04, 2019

The European Medicines Agency¡¦s Committee for Medicinal Products for Human Use (CHMP) has delivered a favorable opinion on Besremi (ropeginterferon alfa-2b) for polycythaemia vera.

The European Medicines Agency¡¦s Committee for Medicinal Products for Human Use (CHMP) delivered a positive opinion on 13 December in adult patients with Besremi (ropeginterferon-alpha-2b) for the treatment of polycythaemia vera without symptomatic splenomegaly (Applicant: AOP Orphan Pharmaceuticals AG). It is available as a solution for injection (250 micrograms / 0.5 ml to 500 micrograms / 0.5 ml). The active substance, ropeginterferon alfa-2b (ATC code: L03AB15), is a new mono-pegylated interferon that inhibits the formation of hematopoietic and bone marrow fibroblast progenitor cells and prevents the growth factors and other cytokines involved in the development of myelofibrosis. Besremi is already in the development phase, 2011.

Following the CHMP¡¦s positive opinion, the European Commission should also allow the product to be placed on the market before it can be made available to patients, the decision of the ECJ is expected at the end of February and early March (67 days after the CHMP opinion is made public).

The product is manufactured in Taiwan by Taichung Science Park (drug developer) by PharmaEssentia, a global manufacturer of biological medicines, and produced by GMA in January 2018. The product is also licensed in the US, Japan and China, and will be marketed in the US and Asia by PharmaEssentia.

Polycythaemia vera (PRV) disease

The disease is associated with a dysfunction of stem cells in the bone marrow. The stem cells produce red blood cells, white blood cells and platelets. In this disease, the number of all three cell groups increases, but the number of red blood cells is very pronounced. The disease occurs more than once in males, the average age at the onset of symptoms is 60 years, and its cause is unknown. Polycythaemia vera is a rare neoplasia of Philadelphia-negative chronic myeloid neoplasia, characterized by hyperviscosity caused by increased red blood cell mass. Headache, dizziness, tinnitus, blurred vision, tiredness are common complaints. After a hot shower, it may cause itchy skin, and the disease may start with nose bleeding, and the patients face may flush. The main cause of morbidity and mortality is the occurrence of arterial and venous thrombotic events,

Clinical trials, safety, side effects

EMA has authorized the preparation based on the data of the PROUD-PV / CONTINUATION-PV clinical development program sponsored by AOP Orphan. The most common side effects with Besremi were leucopenia, thrombocytopenia, arthralgia, fatigue, flu-like symptoms and myalgia.

Our writing is based on the following announcements:

PharmaEssentia and AOP Orphan Receive Positive CHMP Opinion For Besremi ™ (Ropeginterferon alfa-2b) for Treatment of Polycythemia Vera (PV)

What¡¦s new in the diagnosis and treatment of polycythaemia vera

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³Ì·s07 February 2019

www.ema.europa.eu/documents/agenda/agenda-chmp-agenda-28-31-january-2019_en.pdf

P.37/125

Annex to 28-31 January 2019 CHMP Agenda

Pre-submission and post-authorisations issues

P.44/125

B.4. EPARs / WPARs

Besremi - ropeginterferon alfa-2b -

EMEA/H/C/004128, Orphan

AOP Orphan Pharmaceuticals AG, treatment of

polycythemia vera, New active substance (Article

8(3) of Directive No 2001/83/EC)

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www.ema.europa.eu/documents/newsletter/human-medicines-highlights-january-2019_en.pdf

www.ema.europa.eu/en/medicines/human/summaries-opinion/besremi

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(2018)1282/- SANTE (DG Health and Food Safety) [[[23/02/2018 ]]]

COMMISSION IMPLEMENTING DECISION granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for Hemlibra - emicizumab, a medicinal product for human use

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ec.europa.eu/transparency/regdoc/?fuseaction=list&coteId=3&year=2019&number=1455&version=ALL&language=de

C(2019)1455/F1 15/02/2019 C 2019 1455 F1 DG SANTE DURCHFÜHRUNGSBESCHLUSS DER KOMMISSION über die Erteilung einer Zulassung für das Humanarzneimittel Besremi - Ropeginterferon alfa-2b gemäß der Verordnung (EG) Nr. 726/2004 des Europäischen Parlaments und des Rates

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18. Pegasys is not FDA approved for MPN¡¦s and Jakafi is so Insurance has to pay for Jakafi but you need to get Peg off label which some doctors don¡¦t want to deal with.

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·|­û¡G¤p¥¿¥¿10141351  µoªí®É¶¡:2019/2/15 ¤U¤È 02:12:24²Ä 5936 ½g¦^À³
°Ñ¦ÒPolycythemia Vera support group°Q½×¡G

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If interferon(pegysus) is something our body naturally produces, and can potentially cure us, why isn¡¦t that our first line of defense instead of hydroxyurea?

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1.Good question. Has a long answer, to do with attitudes and money. For many years doctors have preferred to treat symptoms rather than the basic problem.

2.It¡¦s not a cure. It puts you potentially into remission but you still have the illness.

3.mpn doctors dont consider it a cure.

4.not sure!

5. Perhaps not enough data over a long enough time for docs to call it cured when someone is able to stop taking pegasys and they remain normal for 5 years.

Anyone out there in that catagory?

5 yrs cancer free is usually when they talk cured.

6. I think it has more to do with the nature of the illness but I am not a doctor.

7. I did notice that it¡¦s extremely expensive.

8.I was under the impression there was no cure for PV

9.Unfortunately for a minority interferon can have really terrible side effects including psychosis and suicidal tendencies so it¡¦s not for everyone.

10.I have been taking Pegasys for over a year.... it is wonderful with no side effects.. my life is ¡§nearly normal¡¨ again... all my labs are normal now and within normal range. Pegasys is $4000 month.. my insurance pays 100%

11.delighted it works for you with no side effects for you and I really do wish that were the case for everyone, hoping that newer generations of the drug will come out so we can all benefit

12.yes I take Pegasus but I do have the side effect of psychosis I only need to take it once a month but I still feel the side effects ugh I hope they come out with something better....

13.you poor thing, please God newer versions get rid of the nastier side effects

14.Pegasys is very expensive , Hu not, money , money, money..,,..

15.Pegasus is much newer treatment for PV and many drs arent familiar with this newer generation of treatment

16.Jakafi ( chemo )--costs much--much more than Pegasys---and it is often prescribed for PV ers--with easier insurance approval.

17.Perhaps because doctors will only prescribe what they are familiar with and what the masses of doctors are prescribing. Unfortunately, to many of the doctors, Interferon has a bad reputation because Hepatitis C folks (taking large quantity of it) were sick from it - note: they were also on other medicine as well. If one stays at 45 mcg / weekly there is none to very little side effects. Some folks at higher dosages do well. I am in hematological remission at 45 mcg / weekly since 8/2016 and may be getting close to molecular remission. I will require another bone marrow biopsy this year to determine if I am in molecular remission.

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·|­û¡GAT10147586  µoªí®É¶¡:2019/2/14 ¤U¤È 09:31:41²Ä 5935 ½g¦^À³
Sorry for correction:

MPN Asia 4/27/2019 (@Korea)

program:

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

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·|­û¡GAT10147586  µoªí®É¶¡:2019/2/14 ¤U¤È 09:25:14²Ä 5934 ½g¦^À³
MPN Asia 4/27 2019 (@ Korea) agenda

mpnasia.com/site/mypage.aspx?pid=173&lang=en&sid=1206

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·|­û¡G¤p¥¿¥¿10141351  µoªí®É¶¡:2019/2/13 ¤W¤È 12:53:45²Ä 5933 ½g¦^À³
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Starting pegasys soon

One option is to have it injected at the hospital oncology clinic.

It will be paid for by Medicare B.

Anyone pay for it this way as opposed to insurance pharmacy plan? (mine is they anthem blue cross)

Trying to figure out the least expensive way to pay for it.

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1.There are grants available to pay for it through PAN foundation. Very easy to apply for.

2. the pharmacy that may fill it will do that after seeing what insurance will charge.

If it¡¦s still crazy, I¡¦ll check into pan and other grant/subside sources.

I¡¦m wondering what Medicare b might charge.

3.I just started on it 4 weeks ago and CVS Specialty Pharm had me apply to the PAN Foundation.. my copay would have been $150 per month

4.I have BCBS they pay all but $50.00 per 4 bottles. It¡¦s easy and convenient to do at home. Trust me I have had a fear of needles all my life but I can do this. Much better than phlebotomies

5.I would prefer to do it at home. I¡¦m a nurse so no big deal to inject myself.

Just looking for the best price. $50 is very doable. Hope it pans out that way for me, too!

6. I do my own injections.

7.It¡¦s very easy, I do at home just make sure you get profiled syringes and not vials it¡¦s much easier.

8.I would call customer service for both and find out directly, because I also have BCBS and my plan only pays 90% after I hit my $500 deductible, so January I had an $834 payment, and after that it is about $360 a month for for me.

9.Super easy to do your own injections...I don¡¦t even feel them....

10.I do my own injections as well (and wasn¡¦t even given any other options). It¡¦s very easy and painless.

11.Very easy to do yourself. I do my own injections at home.

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·|­û¡GAT10147586  µoªí®É¶¡:2019/2/11 ¤U¤È 12:38:35²Ä 5929 ½g¦^À³
www.targetedonc.com/news/expert-underscores-importance-of-gaining-better-understanding-of-mutations-in-myelofibrosis

Title: Expert Underscores Importance of Gaining Better Understanding of Mutations in Myelofibrosis (±M®a±j½Õ¹ï°©ÅèÅÖºû¤Æ¬ðÅܾ÷¨î»Pª¬ªp»Ý­n¶i¤@¨B¤F¸Ñªº­«­n©Ê)

Danielle Ternyila

Published Online:5:23 PM, Fri February 8, 2019

¥»½g­«ÂIÁö¥H¼ÐÃD: ±M®a±j½Õ¹ï°©ÅèÅÖºû¤Æ¬ðÅܶi¤@¨B¤F¸Ñªº­«­n©Ê

¦ý¬O¤å¤¤«ü¥X: ·í¤µÂå¾Ç¹ïMPN °©Åè¼W¥Í©Ê¸~½F »P MF°©ÅèÅÖºû¤Æ ¯f¤H¤§°ò¦]¬ðÅܪº´x±±»P¹ï¯gªvÃĪº­«­n©Ê¬Û¹ï§C¦ô¥B¤F¸Ñ¦³­­. ¡K¡K.. ¤å³¹¥½¤F¦ü¥GÂI¥X¤F¬J¦sªº¡¦¡¦¦ÑÃÄ¡¦¡¦ ¤zÂZ¯À (interferon) ¦b2018 ASH ¦~·|¤¤µoªí¤F¤zÂZ¯À»PHUªº¤ñ¸û (À³¥Î¦b ET / PV)¼Æ¾Ú«á, ¹ï¤zÂZ¯À¦ÑÃĪº¦A¦¸µo´­¥ú¤j¦ü¥G¥Rº¡µÛ´Á±æ

¡K¡K..It¡¦s a very nice paradigm to really highlight that JAK inhibitors are not necessarily targeting the JAK2 mutation¡K..

TARGETED ONCOLOGY: Are there any advancements in PV or ET that you would also like to highlight?

Fleischman: At ASH 2018, there were a number of oral abstracts directly comparing interferons with hydroxyurea in the upfront setting for PV and ET. Although interferon is an old drug, it has been used in MPNs for many years, and this year¡¦s ASH highlighted the benefits of interferon in the upfront setting. We¡¦re potentially entering a renaissance of interferon. What¡¦s interesting is we are searching for lots of new agents that impact disease course, but yet we have had an agent for many years that is able to induce molecular remissions in patients, which is interferon.

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·|­û¡G¤p¥¿¥¿10141351  µoªí®É¶¡:2019/2/9 ¤U¤È 12:08:12²Ä 5928 ½g¦^À³
Name of Activity: 11th International Congress on Myeloproliferative Neoplasms

Funding Disclosure: Celgene, Incyte Corporation, Janssen Pharmaceutical R&D, L.L.C., Novartis, PharmaEssentia Corp, Promedior

Date and Time: October 25-26, 2018

Location of Activity: New York, New York

The Importance of Interferons in the Treatment of MPNs: Current and Future

Why Interferons Need to be the Initial Frontline Therapy for the Treatment for MPNs

Jean-Jacques Kiladjian, MD, PhD

Current Status of Interferon Combination Therapy in the Treatment of MPNs

John Mascarenhas, MD

Clinical Experience with Ropeginterferon Alpha-2b in a Compassionate Use Program

Chih-Cheng Chen, MD, PhD

Moderator: Richard T. Silver, MD

Ropeginterferon alfa 2b is an investigational medical product, which has no marketing authorization in the United States and has to date not yet been reviewed by FDA for its safety and efficacy.

This is not an official presentation of the 11th International Congress. This activity has been independently organized by PharmaEssentia. Not CME accredited.

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1.Anyone on HU develop skin cancer. Sense being on HU I have had a tumor removed from my bladder and now skin cancer. I have read that it could be the HU, it has never agreed with me I am always nauseous and now this.

2. Not me, but it has been confirmed with study that HU increases risk of skin cancer. There was a study published but I didn¡¦t save it since I¡¦m not an HU user. One of the reasons I chose interferon over HU. Maybe someone has it if interested. Might want to research Pegasys.

3.It¡¦s frustrating... From what I¡¦ve read/know HU is expected to lower platelets and white but not necessarily hct/hgb (?). It seems to me you have a legitimate case to want to try something else now. I would push for Pegasys it¡¦s the only one that seems to slow or stop the progression. It seems to me (my opinion only) Pegasys is the way to go if possible. My husband just started hu @ 500 x 3 a week. He¡¦s 68 almost 69.

4.Doctors may also prescribe interferon after surgery to reduce the likelihood of the cancer spreading

5.So sorry ! I was on HU for 5 or 6 years! I too was nauseous all the time ,finally talked my doctor to put me on pegasey ! I¡¦ve been on it 1& 1/2_years and doing really good !

6.Yes , I have skin cancer too and doctors say it happens to some on HU

(¤G)Pegasys¸É§U±¡§Î¡G

1.That¡¦s awesome! Good for you. I just found out today that my insurance denied filling my prescription. Doc thinks I¡¦ll get it on appeal tho. We¡¦ll see... This is the exact reason I want to be on Pegasys to hopefully get a result similar to yours. Congrats!!

2.appeals are common. A good Dr willing to argue is likely to win.

3. good luck. That is so great that they help you with grants and subsidies. So you really only need this as a backup. Also check out Pan Foundation - they cover Pegasys no matter what your diagnosis.

4.I saw on an earlier post someone got assistance thru the Pan Foundation. I haven¡¦t chked that one out yet.

5.I got assistance from the PAN Foundation. They approve Pegasys for MPNs. They list it as Philadelphia Negative MPN un their list of diseases that qualify. They also help with other medical expenses.

(¤T)Pegasys¨Ï¥Î±¡§Î¡G

1.The hematologist wants me to start Pegysus next week. Can folks share their experiences and side effects? I am concerned as I am handling Hydroxurea pretty well.

2.Been on Pegasys since last May - and I also take HU. The only side effect has been occasional flu-like symptoms, and while it is controlling my platelets, my RBCs still climb, so I need periodic phlebotomies. I wish I could get off the HU. The one great thing about Pegasys is that is the only med out there that can slow the progression of the disease (Please correct me if I¡¦m wrong, tribe).

3.Just started Pegasys 4 weeks ago. Had severe flu like symptoms after the first injection for about 3 days. The second week was less severe, but I felt off all week. Less and less side effects after each shot. More energy, brain is working well, much better than how I felt on Hydrea. Waiting on the blood test results now. Not getting sore gums anymore.

4. Pegasys for 7 years. No side effects. I live a normal life as before PV.

Worked very well for me

5.The best medicine is Pegasus Hydrea can cause serious problems especially for taking it long term find an MPN specialist and you will be glad you did good luck and God bless you

6.I¡¦m JAK2 positive PV. I¡¦ve been on Pegasys for over 2 years. I started on 45mcg moved up to 90mcg. First few months I had a few symptoms, now no symptoms. At numbers have been in range, for a while.

7.Pegasys has been a lifesaver for me.. all my numbers are within normal range ... haven¡¦t needed a pleb since I started Pegasys. Been on it 13 months now.

Pegasys also can stop the progression of PV ..

8.I have Pegasys for a year. I started with 45 mcg and increased to 90,135 and I have been on 180 mcg for past six months. No side effects. My counts are good but my main hope is that the medication will stop the progression of the disease. I am 64 and I exercise daily and I still work.

9.Pegasus is much better than HU, more gentle and less severe. I have been on it for months and no side effects. Don¡¦t be afraid

10.28 months on Pegasys and feeling great ! No phlebotomy needed in 14 months--most of my PV symptoms are completely gone --or very tolerable. The possible side effects printed in these inserts are mostly found when using the higher doses of Pegasys---used to treat Hep C. I have been on a low dose---and that is usually all that is necessary unless you get a doctor who wants the drug to work faster---and ups the dose . That is where the problem can begin . Pegasys is a slow worker --and trying to get it to perform faster is sometimes a recipe for disaster . Start at 45mcg and only consider raising the dose if there is no response after 3 or 4 months. The goal should never be to use 180 mcg---even though some doctors think so. I have few side effects--dry eyes --skin and hair.

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·|­û¡GAT10147586  µoªí®É¶¡:2019/2/1 ¤U¤È 11:42:18²Ä 5926 ½g¦^À³
3/2 meeting:

MPN education foundation- MPN meeting agenda

mpninfo.org/conferences/2019-conference/agenda/

Richard Silver MD PhD Managing PV in 2019

Jean Jacques Kiladjian MD PhD The Future of Interferon in MPNs

4/27 meeting

MPN Asia

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

Ropeginterferon approval in Europe -Dr. Heinz Gisslinger

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³Ìªñ¬F©²¹ï©ó¼W¸ê®×¡AÁÍ©ó«O¦u¡A³£­n¨D¸É¥ó¡]¦p·s»D ¡^¡A¥]¬A·sÃĬãµo¤j©@¤½¥q¡A³£³QÄY®æ­n¨D¸É¥ó¡AµL¤@­Æ§K¡C¥Á¶¡¥ø·~¤]¥u¯à·Ó©x¤èªº¸`«µ¡A¥þ¤O°t¦X¡C¦¹¦¸¼W¸ê¥u¬O«ê¥©¹J¤W¬F©²¬Fµ¦ÁÍÄY¡A¦h¤@¨Ç¸É¥ó®É¶¡¦Ó¤w¡C

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2019.1.15 ¤@针500ÉE¬ü¤¸ªº°ò¦]ªv疗谁¥I±o°_¡H诺华SMA°ò¦]疗ªk©Î¥i[¤À´Á¥I´Ú]

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ÁÙ¦³±wªÌ¦Û¶O$5000~8000/¤ë*12=US$6¸U~9.6¸U/¦~¬I¥´Pegasys.

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....such as Pegasys for mpn¡¦s because they are not approved by our FDA for use on mpn¡¦s and so here you have to pay full price for these drugs in US. So they are used off label. I have found the price for Pegasys here to be from 5000 to 8000 US dollars per month for Pegasys and 10,000 per month for Jakafi... ]

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¦³³o¼Ëªº½èºÃ©TµM«Ü¦n¡A¦ý¤]­n¸Ô²Ó±´°QÂåÀø«OÀI¤¶¤Jªº¯u¹ê±¡§Î¡A

§_«hÃø¥H¸ÑÄÀ¡A¬°¦ó¬ü°ê²{¦b¤w¦³¶W¹L1¸U¦WPV¯f¤H¡A¿ï¾Ü¬I¥´©ù¶Qªº¤zÂZ¯À(Pegasys, Pegintron...)?

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...since now we are seeing more and more patients using interferon and I have not had any experience where an insurance company has not permitted its use.

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...I would receive four 180 mg vials each month and enough syringes and a sharps disposal box. And my copay would be $20 a month!

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8 months ago

Hi ****

I love reading all of your posts, you are undoubtedly one of the most informed persons on this forum, and thank you for keeping us all informed of advances in treatments.

I have a question for you. I have read on the US based MPN Research Foundation a post from a Medicare beneficiary (which I also am but not on meds just yet) that they are having trouble getting meds covered by their drug plan and that prescription plans will not cover meds such as Pegasys for mpn¡¦s because they are not approved by our FDA for use on mpn¡¦s and so here you have to pay full price for these drugs in US. So they are used off label. I have found the price for Pegasys here to be from 5000 to 8000 US dollars per month for Pegasys and 10,000 per month for Jakafi. I know that I could not afford that for very long so when that time comes I assume I will simply be put out to pasture to pass along. My question is: I think I have read on mpn voice that persons with a diagnosis of cancer who are on the UK national health service get all of their prescriptions for free. Is this true, do persons in the UK qualify for free Pegasys and Jakafi if you have a diagnosis of cancer which all mpn¡¦s now are?

Thank you in advance for your answer.

–M

Reply •

******

*****

•in reply to Meatloaf9

8 months ago

Thanks. It hinges on your Local Healthcare. Some offer Pegasys but some only offer the cheaper Interferon version. Your post goes to show why our NHS so great versus Medicare. And why it¡¦s always underfunded!

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¡¦¡¦We are making progress in developing medications for patients with MPNs, but we are in need of a team effort to achieve this goal,¡¨ said Verstovsek, director of the Hanns A. Pielenz Clinical Research Center for MPNs at The University of Texas MD Anderson Cancer Cente¡¦¡¦

¡¦¡¦.......There was 1 study from Europe that suggested that 1 of those new long-acting interferons, called ropeginterferon alfa-2b, may actually be superior to hydroxyurea in the frontline setting in PV patients. Recently, we learned that this agent is going to be approved in Europe by the European Medical Association. It¡¦s a standard therapy for PV along with hydroxyurea. Hopefully, these studies will be done here with the same medication in the United States, so our patients can benefit from it in the future.....¡¦¡¦

¡¦¡¦....In PV, I hope that with ropeginterferon alfa-2b being approved in Europe, then it will come to the United States. Other studies that are United States-based that compared long-acting interferon, peginterferon alfa-2a, with hydroxyurea did not show superiority of one over the other. But this is good to know that they are equally effective and one can prescribe peginterferon alfa-2a as per the guidelines. Our guidelines will say interferon or hydroxyurea. We may have a positive development of ropeginterferon alfa-2b if it¡¦s tested in the United States for our patients here.¡¦¡¦

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MPNRF Initiates CRISPR Project

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·|­û¡GAlan Liu10136094  µoªí®É¶¡:2019/1/16 ¤W¤È 11:44:45²Ä 5870 ½g¦^À³
¯f¤Í¹ÎÅéPolycythemia Vera support group©ó¬ü°ê®É¶¡1/13 ¦³Ãö©óÃĵØÃĪº°Q½×½Ķ¦p¤U, ½Ð°Ñ¦Ò, ÁÂÁ¡C

Kevin Walsh

1¤ë13¤é¤W¤È9:15

Anyone have any recent news on the availability of ropeginterferon in the US?

¦³¤H²M·¡¦³Ãö©óP1101¦b¬ü°êªºªñ´Á®ø®§¶Ü¡H

What about the future - any other up and coming drugs that look promising for PV?

½Ð°Ý¥¼¨Ó¦³¬Æ»ò¬Ý°_¨Ó¥Î©óªvÀøPV«Ü¦³«e´ºªºÃĪ«¶Ü¡H

And finally, for some of you folks that have been around for awhile, what are your thoughts/opinions about the future (say over the course of the next 10 years) as it relates to the treatment of PV?

³Ì«á¡A¹ï©ó¤@¨Ç¤w¸g©MPV¦@¦s¤@¬q®É¶¡ªº¹Ù¦ñ¨Ó»¡¡A±z¹ï¥¼¨ÓPVªºªvÀø¦³¤°»ò·Qªk¡H

I know I¡¦m new here, but I just feel that there has to better treatment options on the horizon that will provide a better quality of life for the many symptoms. I for one am hopeful for an outright cure and I do think this disease is not as rare as they say. I believe there are many folks out there that have just not been officially ¡§diagnosed¡¨ yet.

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Don¡¦t get me wrong, I¡¦m grateful that I (hopefully) have the option to try Pegasys and potentially halt the progression of this disease, but I have to say that I am concerned about what my 2nd option would be if for some reason Pegasys does not work out for me.

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Sorry about the long post, just trying to generate some discussion about the future of treatment for our disease and the likelihood of a cure being discovered. Finally, I wish everyone the best in health and God Bless you all!!

©êºp¥´¤F³o»òªø¡A¥u¬O¸Õ¹Ï¹ï§Ú­Ìªº¯e¯fªvÀøªº¥¼¨Ó¥H¤Îªv¡ªº¥i¯à©Ê¶i¦æ¤@¨Ç°Q½×¡C³Ì«á¡A¯¬¤j®a¨­Åé°·±d¡A¤W«Ò«O¦ö§A­Ì¡I

Liza Gellerstedt Berngartt¡G

Great question and I look forward to hearinf others responses too. I know that Ropeg has done well in Europe and will be available there starting next year. My doctor mentioned that he is working with a colleague to try and get some for a clinical trial in the U.S., so I¡¦ll post about that if I hear anything else. My doctor seems to be very hopeful about the development of targeted treatments in the future. He told me my life expectancy is probably 30-40 years without any developments in the medicine, but that he thinks there will be developments. So I¡¦m pulling for science!!!

³o¬O¤@­Ó«Ü¦nªº°ÝÃD¡A§Ú´Á«ÝÅ¥¨ì¨ä¥L¤Hªº¦^À³¡C§Úª¾¹DRopeg¦b¼Ú¬w°µ±o«Ü¦n¡A¨Ã±N±q©ú¦~¶}©l¦b¼Ú¬w¤W¥«¡C§ÚªºÂå¥Í´£¨ì¥L¥¿¦b©M¤@¦ì¦P¨Æ¤@°_¦X§@¦b¬ü°ê¶i¦æ¤@¨ÇÁ{§É¸ÕÅç¡A¦pªG§Ú¦³¬ÛÃö¸ê°T¡A§Ú·|¤À¨Éµ¹¤j®a¡C§ÚªºÂå¥Í¦ü¥G¹ï¥¼¨Ó°w¹ïPVªvÀøªºµo®i©Ê¥Rº¡§Æ±æ¡C¥L§i¶D§Ú¡A§Úªº¹w´Á¹Ø©R¤j·§¦³30¨ì40¦~¡A¦Ó¨S¦³¥ô¦óÃĪ«¦³«ùÄò¶i®i¡A¦ý¥L»{¬°±N·|¦³¶i®i¡A§Ú¥¿¦b§V¤O¾Ç²ß¬ì¾Ç¡I

Emmanuelle Deschutter¡G

Liza Gellerstedt Berngartt who is your doctor?

Liza, ½Ð°Ý½Ö¬O§AªºÂå¥Í¡H

Liza Gellerstedt Berngartt¡G

Emmanuelle, Dr. Elliot Winton at Emory.

Emmanuelle, ¥L¬OEmoryªºElliot WintonÂå¥Í

Susan Mars¡G

With an office in Boston ... PharmaEssentia is in on-going discussions with the FDA on the best path forward to make ropeginterferon alfa-2b available to patients in the US

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Gentille Barkhordar Farshadfar¡G

Thank you. Great post and thank you also Susan for the info regarding PharmaEssentia. I also know of a clinical study underway in the U.S. for the possibility of reversing the genetic mutation that causes PV. Not sure if the outcome or how long it will take scientists to figure that out, but if successful it will be a cure.

ÁÂÁ¡C«Ü´Îªº¤À¨É¡A¤]·PÁÂSusan´£¨ÑÃö©óÃĵØÃĪº¸ê°T¡C§Ú¤]ª¾¹D¬ü°ê¥¿¦b¶i¦æ¤@¶µÁ{§É¬ã¨s¡A¬ã¨s¦³Ãö©ó¥i¯à·|°f¦V¾É­P²£¥ÍPVªº¬ðÅÜ°ò¦]¡C¤£½T©wµ²ªG©Î¬ì¾Ç®a»Ý­n¦hªø®É¶¡¤~¯à¦³µ²½×¡A¦ý¦pªG¦¨¥\¡APV±N¯à³Qªv¡¡C

Kevin Walsh¡GOut of curiosity do you know the name of the clinical study? I would be interested to read it. Thanks for the comment!

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Gentille Barkhordar Farshadfar¡G

Hi the clinical study is called CRISPR and you can get more info about from :

Michelle Woehrle

Executive Director

MPN Research Foundation

mwoehrle@mpnrf.org

Please post an update here if you have any news

³oÁ{§É¥s°µCRISPR, ¦Ó§A¥i¥H¥Ñ¥H¤U±o¨ì§ó¦h¸ê°T¡G

MPN Research Foundation

mwoehrle@mpnrf.org

Emmanuelle Deschutter¡G

Kevin I asked my specialist but he said it is not for now. May be because they are going to try it in a different hospital first? If I hear anything in NYC I will let you know

Kevin¡A§Ú°Ý¹L§ÚªºÂå¥Í¡A¥L»¡³o¶µÁ{§É¤£¬O²{¦b¡C·|¤£·|¬O¦]¬°¥L­Ì·|¥ý¦b¥t¤@®aÂå°|¶}©l¡H¦pªG§Ú¦b¯Ã¬ù¦³Å¥¨ì¥ô¦ó®ø®§¡A§Ú·|§i¶D§A¡C

Emmanuelle Deschutter¡G

Kevin Walsh who is your specialist?

Kevin, ½Ö¬O§AªºÂå¥Í¡H

Kevin Walsh¡G

Emmanuelle Deschutter Dr. Michael Mauro at Sloan Kettering. I see him for the first time on Friday. Who is yours?

§ÚªºÂå¥Í¬OSloan Kettering ªºMichael Mauro, §Ú¦b©P¤­²Ä¤@¦¸¨£¥L, §AªºÂå¥Í¬O¡H

Kevin Walsh¡G

Ha! That is funny. I¡¦m excited to see him and have heard that he is a great doctor and very knowledgeable.

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Emmanuelle Deschutters¡G

Kevin Walshtry to ask him the question and tell me about his answer. He is brilliant and caring but I am thinking also about Weill Cornell because some specialists there have already told their patient s about Ropeginterferon. Let¡¦s keep in touch. You can PM me

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