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www.mpnresearchfoundation.org/

Dr. Srdan Verstovsek presents results from Ropeginterferon vs Hydroxyurea study at MPN Asia 2018

After a 2 year study, Ropeginterferon proves more effective than Hydroxyurea in symptom improvement and lowering progression rates

May 9, 2018

On March 31st, 2018 roughly 100 hematologists/oncologists and MPN experts from Asia, as well as Europe and the United States, came together at the 3rd annual MPN Asia event to present and discuss recent updates and scientific advancements of Myeloproliferative Neoplasms. A few key takeaways from the event came from the Ropeginterferon vs Hydroxyurea trial. This randomized, 2-year study of Ropeginterferon and Hydroxyurea (HU) concluded that the patients on Ropeginterferon had a 50% decrease of the JAK2 burden as well as a sustained reduction in the allele burden. The Ropeginterferon patients also displayed lower progression rates to Acute Myelogenous Leukemia (AML), proving that the drug appears more effective than HU in the long run.

With that being said, Interferon currently stands alone as a medication that controls the biology of this disease. In an effort to change that, last year the MPN Research Foundation started an Interferon Initiative with the goal of understanding why Interferon works for MPN patients and why it works for some patients and not others. We are hopeful that soon the MPN community will have additional options for access to this medication.

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Q: The results (of PV Conti- data) are very promising. Do experts suggest PV patients to use Ropeg rather than hydroxyurea immediately so that is front-line setting?

Dr. Jean-Jacques Kiladjian: ...after two years, you saw the superiority of interferon over hydroxyurea in terms of maintaining the hematological response and increase in the rate of molecular response...based on this data, I would prefer to start with ropeginterferon as first-line therapy and keep hydroxyurea as a second-line therapy

Dr. Srdan Verstovsek: I would agree.

Dr. Richard Silver: I would agree.

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I would agree, I would agree.

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www.onclive.com/peer-exchange/optimizing-pv-treatment/future-direction-for-polycythemia-vera

Future Direction for Polycythemia Vera

Insights From: Ruben Mesa, MD, UT Health San Antonio

Published: Thursday, Apr 26, 2018

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www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm594395.htm

Dear Mr. Kee,

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Celltrion, Inc. at 23 Academy-ro, Yeonsu-gu, Incheon, from May 22 to June 2, 2017.

This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.

¡¯FDA«ü¥XCelletrionªº»sÃļt©úÅã¹H¤Ï¤FcGMPªº³W©w (significant vioations of current good manufacturing practice)

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

¡¯¦A¦¸»¡©ú¤£²Å¦XcGMP (not conform to cGMP)

We reviewed your firm¡¦s June 22, 2017, response in detail and acknowledge receipt of your subsequent correspondence.

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CGMP Consultant Recommended

Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant, qualified as set forth in 21 CFR 211.34, to assist your firm in meeting CGMP requirements.

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(²¤)

Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer.

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An Alternative Treatment for Hepatitis C: Ropeginterferon alfa-2b (P1101)

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¦b»OÆW20·³¥H¤Wªº¦¨¦~¤H°ª¹F4.4¢H·P¬VC«¬¨xª¢¯f¬r¡]HCV¡^¡A¦Ó¥B¤j³¡¤Àªº¯f±w³£¥¼±µ¨üªvÀø¡C¥Ø«eÁöµM¤fªAª½±µ§Ü¯f¬rÃĪ«¡]DAAs¡^¤wÀò»OÆW衞¥ÍºÖ§Q³¡­¹«~ÃĪ«ºÞ²z¸p¡]TFDA¡^ªº®Ö­ã¨Ï¥Î©óC«¬¨xª¢¡A¦ý¦­´Á¦]¬°»ù®æ©ù¶Q¤]©|¥¼¥þ­±¯Ç¤J¥þ¥Á°·±d«OÀI¡]NHI¡^µ¹¥I¡A¤µ¦~¥H«e¦b»OÆWªºÁ{§ÉÀ³¥Î¤W¡AÁÙ¬O¥H¤G½uªvÀø¨Ï¥Î¬°¥D¡CRopeginterferon alfa-2b¡]P1101¡^¬O¤@³Ð·sªº»E¤A¤G¾J¤Æ¤§¤zÂZ¯À£\-2b¡C§Q¥Î¿W¯SªºPEGylation½¢¦X§Þ³N¡A±N40 kDaªº»E¤A¤G¾J¤À¤lÁäµ²¦b¯S©w¦a²ã®ò»Ä­×¹¢¤zÂZ¯ÀªºN-ºÝ¦ì¸m¡A¨Ã¥D­n§Î¦¨³æ¤@¦¨¥÷ªº¦ì¸m²§ºcª«¡A»s³y¥X¥Ø«e¥@¬É¤W³Ì¯Âªºªø®Ä«¬¤zÂZ¯À¡C¦b¤@­Ó°õ¦æ©ó°·±d§ÓÄ@ªÌªº²Ä¤@´ÁÁ{§É¸ÕÅç©M¨â­ÓºC©ÊC«¬¨xª¢±wªÌªº²Ä¤G´ÁÁ{§É¸ÕÅ礤¡AP1101»P¨ä¥¦ªø®Ä«¬¤zÂZ¯À¬Û¤ñ¡A¨äÃĪ«°Ê¤O¾Ç¯S©Ê©M§@¥Î«ùÄòªº®É¶¡§óªø¡C¨CÂù¶g¬I¥´P1101 360£gg¨Ö¥Î¹p¤Ú«ÂªLªvÀø²Õ¡A¹ïºC©ÊC«¬¨xª¢¯f¬r°ò¦]«¬²Ä2«¬¯f±w¥i¹F¬ù90¢Hªº«ùÄò¯f¬r¤ÏÀ³¡]SVR¡^¡A¦Ó¹ïºC©ÊC«¬¨xª¢¯f¬r°ò¦]«¬²Ä1«¬¯f±w¨C¶g¬I¥´P1101 270£gg¨Ö¥Î¹p¤Ú«ÂªLªºµ²ªG¥ç¥i¹F¨ì80¢HªºSVR¡CªvÀø´Á¶¡¶W¹L90¢Hªº¤£¨}¨Æ¥ó¡]TEAE¡^¬°1¯Å©Î2¯Å¡]³q¥Î³N»y¼Ð·Ç¤£¨}¨Æ¥ó¡ACTCAE¡^¡C©óºC©ÊC«¬¨xª¢¯f¬r°ò¦]«¬²Ä1«¬¯f±wªvÀøµ²ªG¤¤¡AP1101¨Ö¥Î¹p¤Ú«ÂªLªvÀøªº±wªÌ¼~Æ{©MÃþ¬y·P¯gª¬¡A¤Ö©ó±Ä¥Î¨ä¥Lªø®Ä«¬¤zÂZ¯À¨Ö¥Î¹p¤Ú«ÂªLªº±wªÌ¡C±qªvÀø¯u©Ê¬õ¦å²y¼W¥Í¯gªºÃöÁä©Ê²Ä¤T´ÁÁ{§É¸ÕÅç¬ã¨s¤¤¤]Åã¥Ü¥X°ª­@¨ü©Ê¡C¦]¦¹¡AP1101¬O¦³§O©ó¥Ø«eªø®Ä«¬¤zÂZ¯Àªº·s¿ï¾Ü¡A´£¨ÑºC©ÊC«¬¨xª¢¯f±w§ó¤è«KªºÀøµ{¡]¨CÂù¶g¬I¥´¤@°wv.s¨C¶g¬I¥´¤@°w¡^¡A¨Ã¨ã¦³¬Û¦PªºÀø®Ä¤Î§ó¨Îªº­@¨ü©Ê¡C

In Taiwan, the prevalence of hepatitis C virus (HCV) infection among adults aged over 20 years old is high (4.4%), but the majority of them do not get treatment. Although direct antiviral agents (DAAs) are approved by Taiwan Food and Drug Administration (TFDA), they are still expensive and mostly used as second line in clinical practice, and are not fully reimbursed by the national health insurance (NHI). Ropeginterferon alfa-2b (P1101) is a novel pegylated proline-interferon alfa-2b with a 40 kDa branched polyethylene glycol chain conjugated predominantly at its N-terminus with one major positional isomer, resulting in the purest pegylated interferon in the world. In a phase 1 study for healthy volunteers and two phase 2 studies for CHC, P1101 had demonstrated better pharmacokinetic profile and longer duration of action than peginterferon alfa-2a. P1101 360 £gg q2w + RBV has yielded about 90% sustained virological response (SVR) rate for CHC genotype 2 and P1101 270£gg q1w + RBV has yielded 80% SVR rate for CHC genotype 1. Over 90% of treatment emergent adverse events (TEAEs) were grade 1 or 2(common terminology criteria for adverse events, CTCAE). Depression and flu-like symptoms were fewer in patients treated with P1101 + RBV than in those treated with peginterferon alfa-2a + RBV for CHC genotype 1. High tolerability was also shown in a pivotal phase 3 study in treating polycythemia vera. P1101 is therefore an alternative of long-acting interferon with comparable efficacy, better tolerability and more convenient dosing schedule (every-2-week, q2w vs. weekly, q1w) for treating CHC.

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