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¾ã²z¸ÔºÉªº¤@½g¡A¾¨¸`¿ý©M¦¹°Q½×¦ê¦³Ãö³¡¥÷ www.cancernetwork.com/oncology-journal/myeloproliferative-neoplasms-translating-new-discoveries-better-outcomes-better-quality-life 1. One observational prospective study ¡]§Ú·QµØ¤Í̳£ª¾¹D¡^ - overall hematologic response rate was similar for the IFN group and the HU group (70.3% and 70.8%, respectively). - A molecular response¡]decreased JAK2 V617F allele burden¡^¡GIFN group vs HU group ¡]54.7% vs 19.4%¡^ - IFN group demonstrated decreased phlebotomy needs greater improvement in systemic symptoms (vasomotor symptoms, distal paresthesia, and erythromelalgia) - In patients with a JAK2 mutation, better 5-year progression-free survival (PFS) in the IFN group (75.9% vs 47.6%). 2. Treatment with HU was associated with a greater risk of secondary malignancies¡X including acute myeloid leukemia, myelodysplastic syndrome, and skin cancers¡Xcompared with IFN (25% vs 8%); HUªºPÀù·ÀI¡A¤Ñ¤jªº¦n®ø®§ ; P 3. the European LeukemiaNet (ELN) to caution against using HU in young patients (< 40 years)and has led others to advocate for prioritizing IFN as the treatment of choice for effecting cytoreduction in polycythemia vera. ELN¥D±i¦~«C±Ú¸s¥ý¦Ò¼{IFNªvÀø 4. The Myeloproliferative Disorders Research Consortium phase III trial ¡]high-risk newly diagnosed PV or ET) °w¹ï°ª·ÀI¡A·s¶EÂ_PV or ET¡A´Á¤¤¤ÀªR¡G - Overall response rate was 69% in the HU group and 81% in the PEG group (P = .6). - Reduction in palpable splenomegaly at 12 months was more common in the PEG group (71%, compared with 29% in the HU group), µÊ¸~¤jªº¤U°IFN²Õ¸ûÀu - phlebotomy independence was more common in the HU group (0% phlebotomy use, compared with 20% in the PEG group). @@Ó¤H¸ÑŪ¬OHU²ÕµÊ¸~¤j®ø±oºC¡A¦ý¦å²y±þ¦ºªº§Ö¡A¦å®ê·íµM§Î¦¨¤£©ö¡]µÊ¤S¥i¤À¸Ñ¦å¤pªO¡^; )¦ýªø»·¨Ó»¡¡A¬ðÅܪº³y¦å²ÓM¥h°µ§ó¦hªº¦å²y¡A¥[³tMFªº¶iµ{ 5¡ASince the current evidence does not reveal the ideal frontline cytoreductive therapy for polycythemia vera or essential thrombocythemia, we endorse HU or IFN based on patient preference with regard to toxicity profile and ease of administration. We do recommend adherence to the ELN guidelines that advise caution with regard to HU use in younger patients (< 40 years). µ²½×¡GHU, IFN¦U¦³ÀuÂI¡A¯f¤H¦Û¤v¨M©w¡H¡H§O§Ñ¤FHU¦³PÀù¥i¯à |
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¤£¥Î¾á¤ß...¸êª÷¦ÛµM·|¶]¨ì¦³§Q¥i¹Ïªº¦a¤è...¦pªG¤½¥q¸g±o°_¦ÒÅç AOLÁÙ¦s¦b¶Ü??¦Ó¨È°¨»¹¤£¤]¬Oºô¸ôªwªj¯d¤U¨Óªº¦n¤½¥q¶Ü?? Gºô¤µ¤Ñ²×©ó¥X¤F¤@½g¤p§Ì»{¦Pªº¤å³¹¤F!! ·|§ë¸êÃĵإDn¦Ò¶q¤§¤@¤]¬O¥Ø«e30»õ¥ª¥kªº¸êª÷¡AÀ³¸Ó¥i¥H¼µ¨ìÃĤW¥«¾P°â¡A°£«D¦³¤°»ò¯S®í¨Æ¥Ñ¡A¤£µMÀ³¸Ó¤£¥Î¦A¦VªÑªF¶Ò¸ê¡C ³o¤@ÂI¬O«Ü«nªº¡A¥H²{¦b·sÃĤ½¥q¦Ê®a»ô©ñ¡A¥Í§Þ¤S®z¶Õ¡A¥¼¨Ó¶Ò¸ê¶Õ¥²§xÃø¡C¤â¤W²{ª÷³¡¦ìY¸û¤£¨¬¤S°µ¤£¥X¤°»ò¦¨ÁZªº....¯uªº¦MÀI¡C ¨ä¹ê³o¤]¬O¥DºÞ¾÷Ãö¥¢µ¦¡A·d¨ìªü¿ßªüª¯³£¥i¥H¤W¿³Âd¡A¬Æ¦Ü¤WÂd¡A²£¥Í¤F¸êª÷ªº±ÆÀ½®ÄÀ³¡C¦H¹ôÅX³v¨}¹ô°Ú!!...§ë¸ê¤H¦pªG¿ï¿ù¼Ðªº...ü!! ¤p§Ì¤jÁx¹w´ú....¥¼¨Ó¥Í§Þ¥|¶¯¡A¥i¯àÀ³¸Ó¬O´¼Àº¡B¤¤¸Î¡BÃĵظò¥_·¥¬P§a! ¨ä¤¤¡B´¼Àº¬O¬ãµo«¬ªº¤½¥q¡A¤£Â_¬ãµo...¤£Â_±ÂÅv...¤~¯à¦³·½·½¤£µ´ªºÀò§Q¡A¥¼¨Ó¬ãµo¯à¤O¼vÂQ¬Æ¹d¡C¤¤¸Î¬Ý¨Ó°ÝÃD¤£¤j....·d¤£¦n·|¦¨¬°»âÀY¦Ï¡CÃĵØÀR«ÝP1101¤W¥«...¬Ý¬Ý¯f±w¨ì©³¬On¿úÁÙ¬On©RÅo! ¦Ó¥_·¥¬P....ªñ´Á¶Ò¸ê7.2»õ¨Ó§¹¦¨³ÌªñªºÁ{§É¡A¬Ý¬Ý¥¦ªºµu´Á¸òªø´ÁÉ´Úª÷ÃB¡AY¤µ¦~Á{§É¨S¦³Åå¤Hªí²{....«e³~³ô¸·¡F¤Ï¤§...¤]¥i¯à¤j»ï¤j©ñ¡C ¦Ü©óôô....´X¦~¤ºn«®¶¶¯·.....®£©È§xÃø!! J¨¥¶Ã»y¤@¤U....¥H¤W¤½¥q§ë¸ê·ÀI§¡¤j...½Ð¤Å·í§ë¸ê°Ñ¦Ò! |
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to ¤Ñ©R¤j¡G ÁÂÁ§A´£¨Ñªº¸ê°T¡A¤]ªY½à§A³o¼ËªººA«×¤~¬O°È¹êªº¡C Incyte ·|¦³¤µ¤Ñªº¥«È¡AÃöÁäµ´¹ï¤£¬O Jakafi ¡A«á±±j¤jªº pipeline ¤~¬O¥i©Èªº¦a¤è¡C »{²M Incyte «á¡A¦ÛµM´N¤£·|¦³¡y ¬°¤°»ò PROUD-PV study Phase ¢» ¹F¼Ð¡A¦ý Incyte ªÑ»ù«o¨S¦³¶^ ¡z¡A³oºØ²ö¦W¨ä§®ªº½èºÃ¤F! |
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(6446) ÃĵØÃÄ¡G¤½§i¥»¤½¥q±µÀò¼Ú¬w¹Ù¦ñAOP¤½¥q»¼¥æ¤§BESREMI¼Ú·ù·sÃĤW¥«³\¥i¥Ó½Ð¤§²Ä120¤Ñ°ÝÃD·JÁ`²M³æ µo¨¥¤é´Á¡G106/07/05 µo¨¥®É¶¡¡G21:48:04 1.¨Æ¹êµo¥Í¤é:106/07/05 2.¤½¥q¦WºÙ:ÃĵØÂåÃĪѥ÷¦³¤½¥q 3.»P¤½¥qÃö«Y(½Ð¿é¤J¥»¤½¥q©Î¤l¤½¥q):¥»¤½¥q 4.¬Û¤¬«ùªÑ¤ñ¨Ò:¤£¾A¥Î 5.µo¥Í½t¥Ñ: ¤½§i¥»¤½¥q±µÀò¼Ú¬w¹Ù¦ñAOP¤½¥q»¼¥æ¤§BESREMI ¼Ú·ù·sÃĤW¥«³\¥i¥Ó½Ð¤§²Ä120¤Ñ¼Ú·ù¤HÅé¥ÎÃÄ©eû·|°ÝÃD·JÁ`²M³æ(CHMP day 120 list of questions) 6.¦]À³±¹¬I: ¼Ú¬wÃĪ«ºÞ²z§½(European Medicines Agency, EMA) ¤w©ó2017¦~2¤ë23¤é§¹¦¨½T»{¥»¤½¥q¼Ú¬w¹Ù¦ñAOP¤½¥q´£¥XBESREMI (P1101¡^·sÃĤW¥«³\¥i¥Ó½Ð¡]marketing authorization application, MAA¡^¡A¾AÀ³¯g¬°ªvÀø¯u©Ê¬õ¦å²y¼W¥Í¯g(PV)²Ä¤@½u¥ÎÃÄ¡C¥»¤½¥q³¼±µÀòAOP¤½¥q»¼¥æ¤§EMA¼Ú·ù¤HÅé¥ÎÃÄ©eû·|¡]Committee for Human Medicinal Products, CHMP¡^ªº²Ä120¤Ñ°ÝÃD·JÁ`²M³æ(CHMP day 120 list of questions)¡A¥»¤½¥q¥xÆW¹Î¶¤(¥x¤¤¼t¦P¤¯¡B¥x¥_¬ãµo¤Hû¤ÎÅU°Ý¹Î)»P¼Ú¬w¦X§@¹Ù¦ñ¹Î¶¤(AOP Group)¤w¦@¦P¿n·¥§ë¤J¦U¶µ°ÝÃD¤§¦^ÂСC«öEMA ¼f®Öµ{§Ç¡A¹F120 ¤ÑCHMP·|´£¥X°ÝÃD·JÁ`²M³æ(CHMP day 120 list ofquestions)¡A¦bEMA¦¬¨ì¦^Âмf®Ö©Ò´£°ÝÃD¤§«e¡A®É¶¡¬O·|°±¤îpºâ¡]Clock off¡^ªº¡A«·sp®É¡]Clock on¡^«hnµ¥¨ìEMA±µÀò©Ò¦³¦^ÂЪº¸ê®Æ«á¡A¦A°w¹ï©Ò´£¦^ÂЦA¦æ¼f®Ö¡A³o°±¤îp®É´Á¶¡¥i¤¹³\¬O3-6 Ó¤ë¡C 7.¨ä¥LÀ³±Ô©ú¨Æ¶µ:µL |
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https://twitter.com/jjkiladjian J.J. Kiladjian @jjkiladjian 6¤ë6¤é ¦^Âе¹ @AaronGerds @NEJM As phlebotomy may no longer be the best solution, which treatment for polycythemia vera is the most interesting in your opinion? 29% hydroxuyurea 71% interferon alpha 00% JAK2 inhibitor 00% other §ë²¼ 7 ²¼•³Ì²×µ²ªG |
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¥i°Ñ¦Ò¡@Jakafi °Æ§@¥ÎªºÁ{§É¸ê®Æ¡C Serious adverse events during ruxolitinib treatment discontinuation in patients with myelofibrosis. ( www.ncbi.nlm.nih.gov/pubmed/220346580¡@¡^ µ²ªG¬O¡A51¦W¯f¤HªºªvÀø¡A92%ªº¯f¤H¦b¤EӤ뤺´N»Ý°±ÃÄ¡A¦]¬°ÃĪ«Àø®Ä¤£¨Î©Î°Æ§@¥Î¡C |
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Incyte Corporation Announces Top-Line Results From RELIEF Trial Of Ruxolitinib In Patients With Polycythemia Vera * Statistical significance not achieved for the primary endpoint of symptom control; positive trends in favor of ruxolitinib versus hydroxyurea observed * RELIEF trial conducted in patients who were generally well-controlled on hydroxyurea but reporting continued disease-related symptoms, a different population than the pivotal Phase III RESPONSE trial * RELIEF not included in, nor required for, polycythemia vera (PV) sNDA submission; data expected to be presented at an upcoming scientific meeting * sNDA submitted to FDA for PV in June 2014 based on the pivotal Phase III RESPONSE trial demonstrating superior clinical benefit of ruxolitinib over best available therapy in patients resistant to, or intolerant of, hydroxyurea WILMINGTON, Del.--(BUSINESS WIRE)--Incyte Corporation (Nasdaq: INCY) today announced top-line results from RELIEF, a randomized, double-blind clinical trial designed to compare symptom improvement in 110 patients with polycythemia vera (PV) treated with ruxolitinib versus patients treated with hydroxyurea (HU). While positive trends were observed in favor of ruxolitinib, the trial did not achieve statistical significance for the primary endpoint as measured by the proportion of patients with = 50% reduction in a defined cluster of symptoms that included tiredness, itching, muscle aches, night sweats and sweats while awake at week 16 compared to baseline. Topline results showed a 43.4% symptom response rate in the ruxolitinib arm and a 29.6% symptom response rate in the hydroxyurea arm (p=0.139). Full data from the RELIEF trial are expected to be presented at an upcoming scientific meeting. Incyte¤½¥q«Å§G¦b¬õ²ÓM¼W¦h¯g±wªÌ¤¤RuxolitinibªºRELIEF¸ÕÅ窺³»½uµ²ªG *¯gª¬±±¨î¥Dn²×ÂIµL²Îp¾Ç·N¸q;Æ[¹î¨ì¾|¥q´À¥§»Pßm°ò脲ªº¿n·¥ÁÍ¶Õ * RELIEF¸ÕÅç¦b¤@¯ë¹ïßm°ò脲±±¨î¨}¦nªº±wªÌ¤¤¶i¦æ¡A¦ý³ø§i«ùÄòªº¯e¯f¬ÛÃö¯gª¬¡A¤£¦P©ó²Ä¤T¶¥¬qªºÃöÁä¤ÏÀ³¸ÕÅç * RELIEF¤£¥]¬A¦b¬õ²ÓM¼W¦h¯g¡]PV¡^sNDA´£¥æ¤¤¡A¤]¤£¬O¥²»Ýªº;¹wp±N¦b§Y±NÁ|¦æªº¬ì¾Ç·|ij¤W´£¥æ¼Æ¾Ú * sNDA©ó2014¦~6¤ë®Ú¾ÚÃöÁ䪺²Ä¤T¶¥¬q¤ÏÀ³¸ÕÅç´£¥æµ¹FDA¶i¦æ¥ú¥ñµû¦ô¡AÃÒ©ú¤F¾|¯Á´À¥§ªvÀø¹ïßm²ã®ò»Ä@¨ü©Î¤£@¨üªº±wªÌªº³Ì¨ÎªvÀø®ÄªGÀu©óÁ{§ÉÀø®Ä ¬ü³qªÀ«Âº¸©ú¹y - ¡]¬ü°ê°Ó·~¸ê°T¡^--Incyte¤½¥q¡]¯Ç´µ¹F§JªÑ²¼¥N½X¡GINCY¡^¤µ¤Ñ«Å¥¬±À¥X¤@¶µÀH¾÷Âùª¼Á{§É¸ÕÅç¡A¦®¦b¤ñ¸û110¨Ò¯u©Ê¬õ²ÓM¼W¦h¯g¡]PV¡^±wªÌªº¯gª¬§ïµ½¡A¥Î¾|¥q´À¥§ªvÀø»P¥Îßm°ò脲¡]HU¡^ªvÀøªº±wªÌ¬Û¤ñ¡CÁöµMÆ[¹î¨ì¦³§Q©ó¾|¹W´À¥§ªº¿n·¥ÁͶաA¦ý¬O¹ï©ó¥Dn²×ÂIªº¸ÕÅç¨S¦³¹F¨ì²Îp¾ÇÅãµÛ©Ê¡A¦p³q¹L¥]¬A¯h³Ò¡Aæ±Äo¡A¦Ù¦×»Äµh¡A©]¶¡¦½¤ô¦b¤ºªº©w¸qªº¯gª¬²Õ´î¤Ö50¢Hªº±wªÌªº¤ñ¨Ò©Ò´ú¶qªº¨Ã¦b²Ä16¶g»P°ò½u¬Û¤ñ¿ô¨Ó®É¥X¦½¡C¹ï·Ó²Õµ²ªGÅã¥Ü¡A¾|¥£´À¥§²Õªº¯gª¬¤ÏÀ³²v¬°43.4¢H¡Aßm°ò脲²Õªº¯gª¬¤ÏÀ³²v¬°29.6¢H¡]p = 0.139¡^¡C¹w´Á¦b§Y±NÁ|¦æªº¬ì¾Ç·|ij¤W±N´£¨Ñ¨Ó¦ÛRELIEF¸ÕÅ窺§¹¾ã¼Æ¾Ú¡C Jakafi¯uªº¦³¤ñ¸û¦n¶Ü?? Gºô...§A¨º»ò±M·~¤]¬ã¨s¤@¤U¹À.....ŪªÌ´£°Ý..... |
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QQ±z¦n¡A³oÓ¸ÕÅçDr. Silver°µ¤F¦n´X¦~¡A·í®É¬O¥H¤W¥«ªºPegasys©MPegIntron¨Ó°µ¸ÕÅç¡A±q³o¸ÕÅçµ²ªG¥i¥H¹w´Á¦P¬°Recombinant Interferon-aªºP1101¨ã¦³¦P¼Ëªºremission¯à¤O(¦Ó¥B°Æ§@¥Î§ó¤Ö)¡A§Y¨Ï¥Ø«eMFªº¤@½u¥ÎÃÄjakafi³£µLªkªý¤î¦´ÁMF¯f±¡progression¨ì«á´ÁMF¡C ÁÂÁÂAlan Liuºë·ÇªºÂ½Ä¶¡Aèè§ä¨ì³o¬ã¨sµ²ªG¤w¥¿¦¡µoªí¦bCancer´Á¥Z¦p¤U¡AºKn¦³§ó¦hªºµ²ªG¼Æ¾Ú¡C www.ncbi.nlm.nih.gov/pubmed/28518222 |
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·PÁ ¤pªL«e½ú¤À¨É, ¯S¦¹Â½Ä¶¦p¤U¨Ñ¦U¦ì§ë¸ê¥ý¶i°Ñ¦Ò¡C MPNforum Magazine Summer, 2017 mpnforum.com/ Silver ¡V When to treat with Interferon¡Kmolecular study yields compelling data. (¤zÂZ¯À¥ýÅX) Silver Âå¥Í- ¦b¦ó®É¥Î¤zÂZ¯À¶i¦æªvÀø¤W, ¨ä¤À¤l¤ÏÀ³¬ã¨sÅã¥Ü¥O¤Hª`¥Øªº¦¨ªG¡C It was a small trial, 16 women and 14 men, but it will have a big impact. The result of the study,¡§The Effect of Initial Molecular Profile on Response to Recombinant Interferon-a Treatment in Early Myelofibrosis will be published in the upcoming American Cancer Society¡¦s journal, Cancer. Lead author is interferon pioneer Dr. Richard T. Silver with an international crew of co-investigators. (Dr. Hans Hasselbalch appended a detailed analysis of the report in the issue, Dr. Nick Cross is one of the co-authors.) ³o¬O¤@¶µ¤p«¬¸ÕÅç, ¥]§t 14 ¦ì¨k©Ê»P 16 ¦ì¤k©Ê, ¦ýµ²ªG«o¦³Åå¤Hªº¼vÅT¡C¹ï©ó°©ÅèÅÖºû¤Æ(MF)ªì´Á¹B¥Î«²Õ¤zÂZ¯ÀªvÀø©Ò²£¥Í¤À¤l«¬ºAªº¼vÅT±N·|¦b±µ¤U¨Óªº¬ü°êÀù¯g¨ó·|´Á¥Z¤¤µoªí¡C¥Dn§@ªÌ¬O¤zÂZ¯Àªº¥ýÅX Silver Âå¥Í¥H¤Î¥Lªº°ê»ÚÁp¦X¬ã¨s¹Î¶¤ (Hans Hasselbalch Âå¥Í¦b³oÓijÃD¤Wªþ¤W¤F¸Ô²Óªº³ø§i¤ÀªR, Nick Cross Âå¥Í¤]¬O¦@¦P§@ªÌ¤§¤@¡C) Data from the study adds another strong molecular-based argument in favor of early use of interferon in treating MPN patients. ¡§The use of low-dose rIFNa in ¡§early¡¨ PMF, post-ET MF,and post-PV MF¡Kresulted in bone marrow reversion, regression of splenomegaly, and disease stabilization with tolerable toxicity in 73% of patients.¡¨ The cohort ¡X median treatment duration 5.6 years ¡X reflected the early MPN population: median age, 58 years, 22 were classified as low risk, and 8 were classified as intermediate-1 risk. The takeaway message: Molecular profiling at the time of diagnosis may predict prognosis and treatment response. ¸Ó¬ã¨s¼Æ¾Ú©Ò´£¥X¤@Ó©úÅ㪺¤À¤l¤ÏÀ³, ÃÒ©ú°©Åè¼W¥Í©Ê¸~½F(MPN)¯f±w©ó¦´Á¨Ï¥Î¤zÂZ¯ÀªvÀø¬O§ó¦³§Qªº¡C¨Ï¥Î§C¾¯¶qªº¤zÂZ¯À¦b¦´Á PMF¡BET ºt¶i¨ì MF ªº¯f±w¥H¤Î PV ºt¶i¨ì MF ªº¯f±w¤W, ¥i¥Hµo²{°©Åè½w¸Ñ¡BµÊ¸~¤jªº¯gª¬®ø°£¥H¤Î 73%ªº¯f±w¦b¯gª¬Ã©w±±¨îªº±¡ªp¤U°Æ§@¥Î@¨ü«×°ª¡C³oÓ¹êÅç²Õ¦¨¥§¡ªvÀø®É¶¡ 5.6 ¦~(¤ÏÀ³¥X³o¬O¦´Á°©Åè¼W¥Í©Ê¸~½Fªº¯f±w¸s)¡B¥§¡¦~ÄÖ 58 ·³¡B¨ä¤¤ 22 ¦ì¯f±w¬O³QÂkÃþ¬°§C·ÀI, ¦Ó¥t¥~ 8 ¦ì¬O¤¤¯Å-²Ä 1 µ¥¯Å·ÀI¸s¡C³o»¡©ú, ¶EÂ_®Éªº¤À¤l¤ÀªR¥i¹w´ú¹w«á©MªvÀø¤ÏÀ³¡C |
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½Ð°Ý¥H¥Ø«eªº¶i«×¤Î²{¦bªº¥«³õ ¦³¤j¤jÌÄ@·N¤À¨É¤ÀªRÃĵإ¼¨Ó¹w¦ôªºEPS¤ÎªÑ»ù¶Ü? ¹L¥hº¡¦h¤j¤j¤À¨É¹L¬Ýªk~ ¦ý¬Û«H¦b³oÀþ®§¸UÅܪº¥«³õ¡A¹w¦ôÈ·|ÀHµÛ«Ü¦h¦]¯À¦Ó§ïÅÜ ¤p©f¥Ø«e¸êª÷¤£°÷¥u¯à¥H¹sªÑ¤è¦¡¤£©w´Á¤£©wÃB¶R¤JÃÄµØ ©Ò¥H§Æ±æ¯à¦h¦hÅ¥¦U¦ìµØ¤ÍÌ«e½úªº¬Ýªk ·íµM§ë¸ê¦³·ÀI~·l¯q¦Ût~ ¥ýÁÂÁÂÄ@·N¤À¨Éªº¤j¤jÌ~ |
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·|û¡G¥ý¶i10000164 µoªí®É¶¡:2017/6/30 ¤U¤È 08:06:09²Ä 2519 ½g¦^À³
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ȱoÃöª`ªº¬ã¨sµ²ªG... £D¤zÂZ¯À¹ïªì´ÁMF¯à¹F¨ì«Ü¦nªºremission®ÄªG¡C ¨Ó·½¡G MPNforum 杂§Ó(®L©u¡B2017) 银µP-当ªv疗¤zÊð¯À...¤À¤l¬ã¨s±o¥X¥O¤H«HªAªº数Õu¡C 这¬O¤@间¤p«¬ªº审§P¡B16 妇¤k©M 14 ¦W¨k¤l, ¦ý¥¦将¦³«Ü¤jªº¼v响¡C 该¬ã¨sªº结ªG, ¡§¼v响¤À¤lªºªì©l°t¸m¤å¥ó问题¦^应«组¤zÊð¯Àªºªv疗¦b¦´Á Myelofibrosis 将发ªí¦b§Y将举¦æªº¬ü国Àù¯g协会ªº杂§Ó¡BÀù¯g¡C ¥Dn§@ªÌ¬O¤zÊð¯Àªº¥ý驱²z¬d¼w¡P³Õ¤h¡P银国际Éó组¤H员ªº¦@¦P调¬d员¡C ³Õ¤h 汉´µ¡P Hasselbalch ªþ¥[¤F¤@项详细ªº¤ÀªR报§iªº问题, ®a辉³Õ¤h¬O¤@¦W¦@¦P§@ªÌ¡C) 数Õuªº¬ã¨s¼W¥[¤F¥t¤@Ïú强¦³¤Oªº¤À¤l为°ò础ªº论Õu, ¦³§Q¤_¦´Á¨Ï¥Îªº¤zÊð¯À¦bªv疗¯f¤Hªº MPN¡C ¡§¨Ï¥Î§C剂¶q rIFNa ¦b ¡§¦¡¨, PMF ¦Z ET MF¡B©M PV MF ...导P°©Åè¦^归, ¦^归ªº splenomegaly ©M¯e¯fªº稳©wÉO¥i®e§Ôªº¬r©Ê 73% ªº¯f¤H¡¨ ªº¸s组-¥§¡ªv疗时间 5.6 ¦~-¤Ï¬M¤F¦´Áªº MPN ¤H¤f: ¦~龄¤¤¦ì数¡B58 ¦~¡B22 ³Q归类为§C风险¡B8 ³Q归类为¤¤间-1 风险¡C 将«Å传讯®§: ¤À¤lªº©Ê¯à¤ÀªR¦b诊断¥i¯à会预测预¦Z©Mªv疗¤Ï应¡C |
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·|û¡G¤pªL10142678 µoªí®É¶¡:2017/6/30 ¤U¤È 07:22:29²Ä 2518 ½g¦^À³
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ȱoÃöª`ªº¬ã¨sµ²ªG... £\¤zÂZ¯À¹ïªì´ÁMF¯à¹F¨ì«Ü¦nªºremission®ÄªG¡C ¨Ó·½¡GMPNforum Magazine (Summer, 2017) Silver ¡V When to treat with Interferon¡Kmolecular study yields compelling data. It was a small trial, 16 women and 14 men, but it will have a big impact. The result of the study, ¡§The Effect of Initial Molecular Profile on Response to Recombinant Interferon-a Treatment in Early Myelofibrosis will be published in the upcoming American Cancer Society¡¦s journal, Cancer. Lead author is interferon pioneer Dr. Richard T. Silver with an international crew of co-investigators. (Dr. Hans Hasselbalch appended a detailed analysis of the report in the issue, Dr. Nick Cross is one of the co-authors.) Data from the study adds another strong molecular-based argument in favor of early use of interferon in treating MPN patients. ¡§The use of low-dose rIFNa in ¡§early¡¨ PMF, post-ET MF,and post-PV MF¡Kresulted in bone marrow reversion, regression of splenomegaly, and disease stabilization with tolerable toxicity in 73% of patients.¡¨ The cohort ¡X median treatment duration 5.6 years ¡X reflected the early MPN population: median age, 58 years, 22 were classified as low risk, and 8 were classified as intermediate-1 risk. The takeaway message: Molecular profiling at the time of diagnosis may predict prognosis and treatment response. |
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·|û¡G¤p°¨10135228 µoªí®É¶¡:2017/6/30 ¤U¤È 04:52:08²Ä 2517 ½g¦^À³
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¨ä¹ê¸Ü¤S»¡¦^¨Ó ¤½¥q³sPen-PVªºª`®g¾¹³£¨q¥X¨Ó¤F Ãĵýªº¨ú±o¥i»¡¬O±´Ån¨úª«¡D¡D¡D ·Q·Q´XÓ¤ë«e´¹¤ß¤W¥««e¡A§Ú60¦h¤¸¶R¨ì¤â³n¡A ÁÙ¬O¦³¤H¤j§â¤j§âªº½æ(·íµM§ÚÃä¤j§â¤j§âªº±µ) §Ú¤]»¡¤F¡A¦³¤H§âÆp¥Û·í¥ÛÀY½æ¡An·íÆp¥Û¦Ü¤Ö¤]n200¤¸¥H¤W §ó¤£¥Î»¡ªÑ»ù¥u¦³60´X ªG¤£¨äµM¡A´¹¤ß±¾µP«á´N¯¸¤W¤F200¤¸ |
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³o´N¥s¬~½L,¨ä¹êªø´Á§ë¸ê¤£¥Î¤Ó¦b·Nº¦¶^,´N¹³´X¦~«e§ë¸ê¤j¥ß¥ú,²{¦b¤£¬OÁȧó¦h¶Ü,ªø´Á§ë¸ê,ªø´Á§ë¸ê,ªø´Á§ë¸ê |
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·|û¡G¤p°¨10135228 µoªí®É¶¡:2017/6/30 ¤U¤È 01:49:28²Ä 2515 ½g¦^À³
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µo¥Í¤F¤°»ò¨Æ¡H ¦½L¦è©a©a¡A¦¬½L½¬õº¦2.5¤¸ ¨º¨Ç°l±þªº¤H¤£´N®º¯}¤F¡H |
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·|û¡G¥ý¶i10000164 µoªí®É¶¡:2017/6/30 ¤W¤È 10:22:55²Ä 2513 ½g¦^À³
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¡m¥ÍÂåªÑ¡n¥Í§Þ®iº¤é¡A(6446)ÃĵØÃĨqPEN-PVª`®g¾¹ 2017/06/29 13:06:27 ¡i®É³ø°OªÌ³¢ÂE¼z¥x¥_³ø¾É¡jÃĵØÂåÃÄ(6446)¦b¤µ¤éµn³õªº¡u2017¦~¥Íª«¬ì§Þ¤j®i¡v¡A®i¥ÜºX¤U¸ÕÅ礤·sÃÄP1101ªvÀø¯u©Ê¬õ¦å²y¼W¥Í¯g(PV)±Ä¥Îªºª`®gµ§(PEN-PV)¡A¦¹¤@ª`®gµ§¨ã¦³±M§Q¡A¥un«öÀ£§Y¥i¥H¨Æ¥ý°t¦nªº¾¯¶q¦Û°Êµ¹Ãħ¹¦¨ª`®g¡A¹w´Á¥i¥H´î¤Ö¯f±wÀWÁc¦^¶E±µ¨üÃĪ«ª`®gªºt¾á¡A¨Ã´£°ªªAÃÄ¿í±q©Ê¡C ÃĵØÃĪí¥Ü¡A¥Ø«eP1101ªvÀøPVªº¸ÕÅ礤·sÃĤw¥ÑAOP¤½¥q©ó¼Ú·ù¥Ó½ÐÃÄÃÒ¤W¥«¼f®Ö¤¤¡F¦b¬ü°ê³¡¤À¡A¥ÑµS¥L¤j¾ÇÂå¾Ç³¡¦å²G¾Ç±Ð±ÂJose f T. Prchal³Õ¤h°µ¬°¸ÕÅçpµe¥D«ù¤H¡A¦VFDA»¼¥æªº¡u°w¹ï¥ý«e¨Ï¥ÎPegasysªvÀø¯f¤H§ï±Ä¥ÎP1101®¦·OÀøªk¡vÁ{§É¸ÕÅç¡A¤]Àò®Öã°õ¦æ¡CµS¥L¦{¬O¬ü°ê¤Ö¼Æ¤£¦P·N±µ¨ü¥é³æ®Öã¾AÀ³¯g¥~ªº¨Ï¥ÎÀøªk(off-label use)ªº¦a°Ï¡A¤]´N¬O»¡¡A¥²¶·¸gFDA®Öã¤W¥«ªºÃĪ«¤~¯à¶}¥ßµ¹¯f¤H¡C¦Ó¦¹®¦·OÀøªkÁ{§É¸ÕÅ窺®i¶}¦³§U¥¼¨ÓP1101Àòã¤W¥««á¦b¬ü°êPV¯e¯f»â°ìº¯³z²vªº´£¤É¡C ÃĵØÃÄ«ü¥X¡AP1101¬O¾A¥Î»â°ì³Ì¼sªº¤zÂZ¯À¡A¥Ø«e¸ÕÅ礤·sÃĶi¦æªº¾AÀ³¯g¡A°£¤F¥|¤j¦å²G¯e¯f(PV¡B¦å¤pªO¼W¥Í¯g¡BºC©Ê°©Åè©Ê¥Õ¦å¯f¡B°©ÅèÅÖºû¤Æ)¥~¡AÁÙ¥]¬A¨xª¢¡A¦pºC©ÊC«¬¨xª¢(HC V-GT2¡A¥xÆW¡BÁú°ê¤T´ÁÁ{§É¶i¦æ¤¤)¡BºC©ÊB«¬¨xª¢(HBV¡A¥xÆW¤G´ÁÁ{§É¶i¦æ¤¤)¡A¥H¤Î¸~½FÀù¯g(¨xÀù¡B¶Â¦â¯À½F)»â°ìµ¥¡C |
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·|û¡G¤p¥øÃZ10142872 µoªí®É¶¡:2017/6/30 ¤W¤È 09:02:11²Ä 2512 ½g¦^À³
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ÁÙ¬O§Ô¤£¦í¥X¨Óµo¨¥¤@¤U.... ªÑ»ù¬°¤°»ò³o¼Ë??¦U¦ì´Nª¾¹D§Ú¬°¤°»ò¨º»ò¤£³ßÅwGºô¤F...¤@ª½Ä±±o¤½¥qÀ³¸Ó¹ï¥¦´£§i...¶Ã½èºÃ¤@¦¸´N§i¤@¦¸!! ¦³¾Ì¦³¾Ú´N¥X¨ÓÁ¿¤@Án...³oÓÃĨS¦³¤j®a·Q¹³ªº¨º»ò¦n...©Î®³¨ìÃÄÃÒ¦³°ÝÃD...¤§Ãþªº¡C¬Û«H¤j®a³£ÁÙ·|·PÁÂ¥¦ªº¡X¡X±M·~¡C¦Ó¤£¬O¨C¦¸¦³¤°»ò¶i®i...´N²Ä¤@®É¶¡¸õ¥X¨Ó½èºÃ¤@¤U¡C§ë¸ê¤Hªº¼ö¦åÀþ¶¡³£³Q¥¦¼å®§¤F.... ±¹ï¤@½g¤S¤@½gªº½èºÃ....½ÖÁÙ¶Rªº¤U¤â¡C¨S¦³¶R½L...þ¨ÓªºªÑ»ù?? ¨ü¶Ëªº¬O½Ö....¬O§Ú̳o¨Ç¤â¤W¦³«ùªÑªº§ë¸ê¤H¡CÁöµM³£¬O±b±·l¥¢¡A¦ý¬Û«H¤j®a¤ß±¡³£¤£¦n¡C |
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¨ä¹ê¬Q¤ÑªºªÑªF·|¨S¦³»¡¤°»ò¤º®e¡A³æ³æij¨Æ¶i¦æ¤Îªí¨M(©Ó¿Õ¨Æ¶µ2¶µ¤Î°Q½×¨Æ¶µ4¶µ)´N¥Î±¼1¤p®É¡C ¥u¦³Á{®É°Êij®É¦³ªÑªFn¨D¦æ¾P¥¬§½¤§»¡©ú¡C ªL°õ¦æªø¤§»¡ªk»P«°T¤º®e®t¤£¦h¡AºKn«ÂI¦p¤U¡A¦]¤p§Ì§Ú«D±M®a¡A¦p¦³¿ù»~ªº¸Ü¡AÁٽЬÛÃö¤j¤j«ü¥¿¡C 1. ¤½¥q«ùÄò¬ãµo¡A±N´Â¦V¥þ¤è¦ìªº¥Í§Þ¤½¥q¡C 2. AOP°£PV¤T´Á¥~¡AP1101¨Ã¦³»P¨ä¥LÂå¥Í¦X§@¨ä¥L4~5Ó¾AÀ³¯g¤§ÂX¥R(¤½¥qºô¯¸¤W¦³´£¨ì)¡A¦ý¤£ºâ¬O¥¿¦¡Á{§É¡A¨Ò¦pCMLµ¥¡A¬O¬°¤F«áÄò¦æ¾P¤§¥Î¡C 3. ¬ü°ê¦æ¾P¥¬§½¡A¤l¤½¥q¬ù4Ó¤H(¥H«e¦P¨Æ)¡A¦]¸êª÷¨¬°÷¡A¥Ø«e³W¹º¥Ñ¦Û¤v¨Ó¦æ¾P¡Aµ¥´x´¤§ó¦hÄw½X«á¦A½Í¦X§@¡C 4. ¤é¥»¦æ¾P¤è±¡A¤l¤½¥q¦³2.6¤H¡A¨Ã¥Ñ¤pªQ±Ð±Â¶i¦æ«áÄò¤§Á{§É¤u§@¡C 5. ¤¤°ê¤è±¡A³z¹L¦b»´ä¦¨¥ß¤l¤½¥q¡A¦A³z¹L¤¤°ê¹Î¶¤»P¤l¤½¥q¦X¸ê¤½¥q«á¡A¶ix¤¤°ê¦¨¬°¥~¸ê¤½¥q¡C¤w¥Ó½ÐP1101Á{§Éµù¥U¡A¦ý¯à¤£¯à60¤Ñ³q¹L¼f¬d¦P·N±Ò°ÊÁ{§É¡AÁÙn¬Ýªk³WªºÅܤơA¦ý¦Ü¤Ö¦³¶i«×¡C 6. ¤¤°êB«¬¨xª¢¤H¤f¦h©ó¥xÆWÁ`¤H¤f¡A¥«³õ«Ü¤j¡A¤zÂZ¯À¦b¥xÆW¹ù¹B½d°|¤h¡B³¯©w«H°|¤h¤Î³¯°öõ°|¤hªº»{¦P¤U¡AÀ³¸Ó¦³¾÷·|¦¨¥\¡C¨ÃÁ|¦b³õªº¬Y¤@¸³¨Æ¬°¨Ò¡A¨ä±µ¨üP1101ªvÀø«á¦³²¬Â¡¡A¨Ã²£¥Í§ÜÅé¡C 7. P1101¤§¦w¥þ¾¯¶q¥i¹F¨ì450¡A¨Ã¥i¤G¶g¤@¦¸¡A¤@¦~«á¥i¨C¤ë¤@¦¸¡C 8. ¤zÂZ¯À¤§¾A¥Î¬OµL©Ò¤£¯àªº¡A¤½¥q¥Ø«eÂê©w¦å²G¤Î¨xª¢¤è±¡C 9. ÃÄÃҥӽг¡¤À¡AEMA¤w¹F¨ì¼f¬d120¤Ñ¨Ã©ó¤§«e´N´£¨ÑP1101 for PV¼f¬d·N¨£¡A±N¨Ì³W©w©ó3~6¤ë¥ÑAOPt³dÁ{§É¦^ÂСA¤½¥q«h¬O¦^µª¦³ÃöCMC¤ÎR &D°ÝÃD¡A¨Ãªí¥Ü¦³«H¤ß¡C 10. ¬ü°êÃÄÃҤ象A¤w©ó4¤ë22¤é»PFDA²Ä¤@¦¸·¾³q¡A±N«ùÄò·¾³q¡C 11. ¤é¥»¤è±¡An¥Ó½Ð²Ä¤@´Á¾ô±µÁ{§É¡A¤´³W¹º¤¤¡A¤Ï¦Ó¤¤°ê¶i«×¤ñ¸û§Ö¤w¥Ó½Ð²Ä¤@´Á¡C 12. Á`¤§¡A¤½¥q·|«ùÄò¬ãµo¡BÁ{§É¡B»s³y¤Î¦æ¾P¡A¥¼¨Ó¤]·|¥@¥N¶Ç©Ó¤Î¥ÃÄò¸gÀ窺¡C¦pªGªÑªF̦³¥ô¦óºÃ°Ýªº¸Ü¡A¤½¥qÀH®ÉÅwªï¸ß°Ý¡A¦ý·|ÁקKIJ¥Ç¤º½u¥æ©ö³á¡C ³Ì«á¡A¤½¥q¦b«n´ä¥Í§Þ®i³]¦³Åu¦ì¡A¦U¦ì¤j¤j¦³ªÅ¦h¥h¤F¸Ñ¤Î¶i¤@¨B¸ß°Ý¡C |
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·|û¡Gwu701610136601 µoªí®É¶¡:2017/6/29 ¤U¤È 01:20:56²Ä 2509 ½g¦^À³
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¡m¥ÍÂåªÑ¡n¥Í§Þ®iº¤é¡AÃĵØÃĨqPEN-PVª`®g¾¹ ®É³ø·s»D 2017/06/29 13:06 ¡i®É³ø°OªÌ³¢ÂE¼z¥x¥_³ø¾É¡jÃĵØÂåÃÄ(6446)¦b¤µ¤éµn³õªº¡u2017¦~¥Íª«¬ì§Þ¤j®i¡v¡A®i¥ÜºX¤U¸ÕÅ礤·sÃÄP1101ªvÀø¯u©Ê¬õ¦å²y¼W¥Í¯g(PV)±Ä¥Îªºª`®gµ§(PEN-PV)¡A¦¹¤@ª`®gµ§¨ã¦³±M§Q¡A¥un«öÀ£§Y¥i¥H¨Æ¥ý°t¦nªº¾¯¶q¦Û°Êµ¹Ãħ¹¦¨ª`®g¡A¹w´Á¥i¥H´î¤Ö¯f±wÀWÁc¦^¶E±µ¨üÃĪ«ª`®gªºt¾á¡A¨Ã´£°ªªAÃÄ¿í±q©Ê¡C ÃĵØÃĪí¥Ü¡A¥Ø«eP1101ªvÀøPVªº¸ÕÅ礤·sÃĤw¥ÑAOP¤½¥q©ó¼Ú·ù¥Ó½ÐÃÄÃÒ¤W¥«¼f®Ö¤¤¡F¦b¬ü°ê³¡¤À¡A¥ÑµS¥L¤j¾ÇÂå¾Ç³¡¦å²G¾Ç±Ð±ÂJose f T. Prchal³Õ¤h°µ¬°¸ÕÅçpµe¥D«ù¤H¡A¦VFDA»¼¥æªº¡u°w¹ï¥ý«e¨Ï¥ÎPegasysªvÀø¯f¤H§ï±Ä¥ÎP1101®¦·OÀøªk¡vÁ{§É¸ÕÅç¡A¤]Àò®Öã°õ¦æ¡CµS¥L¦{¬O¬ü°ê¤Ö¼Æ¤£¦P·N±µ¨ü¥é³æ®Öã¾AÀ³¯g¥~ªº¨Ï¥ÎÀøªk(off-label use)ªº¦a°Ï¡A¤]´N¬O»¡¡A¥²¶·¸gFDA®Öã¤W¥«ªºÃĪ«¤~¯à¶}¥ßµ¹¯f¤H¡C¦Ó¦¹®¦·OÀøªkÁ{§É¸ÕÅ窺®i¶}¦³§U¥¼¨ÓP1101Àòã¤W¥««á¦b¬ü°êPV¯e¯f»â°ìº¯³z²vªº´£¤É¡C ÃĵØÃÄ«ü¥X¡AP1101¬O¾A¥Î»â°ì³Ì¼sªº¤zÂZ¯À¡A¥Ø«e¸ÕÅ礤·sÃĶi¦æªº¾AÀ³¯g¡A°£¤F¥|¤j¦å²G¯e¯f(PV¡B¦å¤pªO¼W¥Í¯g¡BºC©Ê°©Åè©Ê¥Õ¦å¯f¡B°©ÅèÅÖºû¤Æ)¥~¡AÁÙ¥]¬A¨xª¢¡A¦pºC©ÊC«¬¨xª¢(HC V-GT2¡A¥xÆW¡BÁú°ê¤T´ÁÁ{§É¶i¦æ¤¤)¡BºC©ÊB«¬¨xª¢(HBV¡A¥xÆW¤G´ÁÁ{§É¶i¦æ¤¤)¡A¥H¤Î¸~½FÀù¯g(¨xÀù¡B¶Â¦â¯À½F)»â°ìµ¥¡C |
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·|û¡G¤¸®ð¤j¨k«Ä10142490 µoªí®É¶¡:2017/6/29 ¤W¤È 11:24:43²Ä 2506 ½g¦^À³
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·PÁ ¤pªL«e½ú¤À¨É¥~´C·s»D½Z, ¯S¦¹Â½Ä¶¾ã²z¨Ñ§ë¸ê¥ý¶ḭѦҡC AOP Orphan and PharmaEssentia announce latest clinical results for Ropeginterferon alfa-2b in Polycythemia Vera from 3 abstracts presented at the 22nd Congress of the European Hematology Association (EHA) in Madrid AOP ©t¨àÃĤ½¥q©MÃĵØÂåÃĤ½§i¦b°¨¼w¨½ªº²Ä22©¡¼Ú¬w¦å²G¦~·|¤¤3½gP1101 ¦bPV¾AÀ³¯gªº³Ì·sÁ{§Éµ²ªG - Long-term maintenance treatment of Polycythemia Vera (PV) patients with Ropeginterferon alfa-2b administered every 4 weeks is feasible, efficacious and well tolerated. ¬I¥´P1101ªºPV¯f±w¦bªø´ÁªvÀø¤¤¬Ý¥X¨C¥|¶gª`®g¤@¾¯¬O¥i¦æªº¡B¨ã¦³Àø®Äªº»P@¨ü©Ê¨Î¤§¤è¦¡¡C ¯e¯f½Õ¸`¯à¤O¥H¤Î©µ½wPV¯f±w¯e¯f¶i¤@¨B´c¤Æªº§@¥Î¥i¥Ñ³Ì·sÁ{§É¤Î¤À¤l¼Æ¾Ú±o¨ì¤ä«ù¡A²{¤w¥ÑAOP©ó¼Ú·ù¥Ó½ÐÃÄÃÒ¤W¥«¼f®Ö¤¤¡AÃĵØÃijWµe±N¦VFDA¥Ó½ÐÃÄÃÒ¤W¥«®Öã¡C - Home self-administration of individual doses with a pen is well accepted and expected to support adherence in the long-term treatment of PV-patients ®a¥Îµ§«¬ª`®g¾¯¬I¥´¤è¦¡¬O³Q¯f±w±µ¨üªº¥B¹w´Á¥iªø´Á¤ä´©PV¯f±wªºªvÀø¡C - Disease modifying capability of Ropeginterferon alfa-2b and delay of disease progression in PV-patients is supported by latest clinical and molecular data ³Ì·sªºÁ{§É©M¤À¤l¼Æ¾Ú¤ä«ùP1101ªº¯e¯f×´_¯à¤O©M©µ¿ðPV¯f±w¯e¯fªº¶i®i - Ropeginterferon alfa-2b is currently under EMA review for marketing authorization in the EU by AOP Orphan, PharmaEssentia intends to seek FDA approval for Ropeginterferon alfa-2b in the U.S. ·s¤@¥Nªø®Ä«¬¤zÂZ¯ÀP1101¥Ø«e¤w¥ÑAOP¤½¥q©ó¼Ú·ù¥Ó½ÐÃÄÃÒ¤W¥«¼f®Ö¤¤¡AÃĵØÂåÃĤ]³Wµe±N¦VFDA¥Ó½ÐÃÄÃÒ¤W¥«®Öã¡C VIENNA and TAIPEI, Taiwan, June 25, 2017 /PRNewswire/ -- AOP Orphan Pharmaceuticals AG (AOP Orphan) and PharmaEssentia Corporation (Taipei Exchange: 6446) announced latest results from 3 clinical studies on Ropeginterferon alfa-2b for patients with Polycythemia Vera (PV) presented at EHA 2017. ºû¨È¯Ç/¥xÆW¦b2017¦~6¤ë25¤é/·s»D½Z AOP ¤½¥q»PÃĵØÂåÃÄ(ªÑ²¼¥N¸¹: 6446)«Å¥¬¦b2017¦~¼Ú¬w¦å²G¦~·|ªº¤T¶µP1101Á{§Éµ²ªG Ropeginterferon alfa-2b is a novel, long-acting, mono-pegylated proline interferon expected to be the first interferon approved for PV worldwide. It is currently under EMA review for marketing authorization in the EU by AOP Orphan, PharmaEssentia intends to seek its approval by the FDA in the U.S. Ropeginterferon alfa-2b¬O¤@ӳзsªº¡Bªø®Äªº¡B³æ¤@»E¤A¤G¾Jªº²ãÓi»Ä(Proline)¤zÂZ¯À¡A¹wp±N¦¨¬°¥þ²y²Ä¤@Ó³Q®Öã¥Î©óªvÀøPV¯f±w¤§¤zÂZ¯À¡A¥Ø«e¤w¥ÑAOP¤½¥q©ó¼Ú·ù¥Ó½ÐÃÄÃÒ¤W¥«¼f®Ö¤¤¡AÃĵØÂåÃĤ]³Wµe±N¦VFDA¥Ó½ÐÃÄÃÒ¤W¥«®Öã¡A¥H¦æ¾P©ó¬ü°ê¡C Abstract EHA-3520: An update from the PEGINVERA study (NCT: 2010-018768-18) on long-term maintenance treatment of up to 6 years (median of 4 years) with Ropeginterferon alfa-2b was provided. Patients were successfully switched from the once every 2 weeks to the more convenient once every 4 weeks¡¦ long-term maintenance dosing schedule after a median of approximately 2 years. EHA-3520ºKn¡GPEGINVERA Á{§É¸ÕÅç(NCT¡G2010-018768-18)¡A´£¨Ñ¥HRopeginterferon alfa-2bªø´Áºû«ùªvÀø³Ìªø¹F6¦~(¤¤¦ì¼Æ¬°4¦~)¤§³Ì·sµ²ªG¡C¯f±w¦¨¥\¦a©ó¥§¡¬ù2¦~ªº®É¶¡¥Ñ¨â¶g¤@¾¯Âà´«¨ì§ó¤è«Kªº4¶g¤@¾¯ªø´Áºû«ù¥ÎÃĮɵ{¡C All 29 patients could be maintained on this schedule for another 2 years, representing 100% treatment adherence. The high rates of hematological (over 80% of the patients achieved partial or complete hematologic response) and molecular responses (up to 80% of the patients achieved partial or complete molecular response) were maintained after the switch to the 4 weeks¡¦ schedule and remain stable (trial still ongoing). ©Ò¦³29¦ì¯f±w§¡«ùÄòºû«ù¦¹ªvÀø®Éµ{¹F2¦~¡AÅã¥Ü¤F100%ªº¥ÎÃÄ¿í±q©Ê¡C°ª¤ñ¨Òªº¦å²G¾Ç(¶W¹L80%¯f±w¹F¨ì³¡¤À©Î§¹¥þ¦å²G¾Ç¤ÏÀ³)¥H¤Î¤À¤l(³Ì°ª¦³80%¯f±w¹F¨ì³¡¤À©Î§¹¥þ¤À¤l¤ÏÀ³)¤ÏÀ³¦bÂà´«¬°¨C¥|¶g¥ÎÃĮɵ{«á«ùÄòºû«ù¡A¥B«O«ùéw¡]¥»¸ÕÅ礴«ùÄò¶i¦æ¤¤¡^¡C After 4 years on Ropeginterferon alfa-2b, the majority of patients showed a sustained reduction of the mutant JAK2V617F allelic burden to below 10%, demonstrating the disease modifying capability of Ropeginterferon alfa-2b treatment. ¦b4¦~ªºRopeginterferon alfa-2bªvÀø¤§«á¡A¤j |
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·|û¡G¤p°¨10135228 µoªí®É¶¡:2017/6/26 ¤U¤È 12:42:29²Ä 2476 ½g¦^À³
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P1101·sÅã¾Ç °ê»Ú¬ì¾Ç·µ°ó¤W¡A¨q¦Ù¦×¤~¬O«ÂI¡A ¨º¬O«Ü¦h¬ì¾Ç®a¤ß¦å¸ò²MÅAªºI®Ñ¡C P1101±N¦¨¥@¬É·sÅã¾Ç¡C ·Q¹³¥¼¨Ó¼w°ê¡B¼Ú·ùµ¥°êªº¸ê®Æ±N·|¤@¤@ÅS¥X¡A ¬ü°êµ¥¥ý¶i°ê®aªº·s¶i®i¡K.. ºò±µµÛ¡A¤@ªiªi®ö¼é®u±²¦Ó¦Ü¡C ³o¤@¨Ç¥~°ê¸ê®Æ¡A¤@ªi·|±µ¤@ªi¡A½Ķ¾÷³£Â½±o¥X·N«ä¡C ©Ò¥H°ê¤º¡A¦A«½Æµo«°T¡AÀA¤W²Kªá¦¡ªº ©ñ·Ï¤õ ¦ü¥G¤w¤£¬O¨º»ò«n¡C |
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Ó¤Hı±o¡APV ³Ì·sÁ{§É¼Æ¾Ú¡AÀ³¸Ón¥Ñ¤½¥q¥ýµo«°T»¡©ú¡A¦Ó¤£¬O´CÅé¡C¯S§Oªº¬O¡APV Á{§É¤T´Áªº¤À¤l¤ÏÀ³ªº¼Æ¾Ú¬O²Ä¤@¦¸¤½§G²Ó¸`¡A¸ê®Æªº§PŪ¤£¸Ó¥Ñ´CÅé·Q«ç»ò¼g´N«ç»ò¼g¡C ¤À¤l¤ÏÀ³ªº¼Æ¾ÚÃö«Y¨ì¯à§_ªv¡ªºÃöÁä¡A³o¬O·íªì EMA «D±`¬Ý«ªºÂI¡A¤]¦]¬°¦p¦¹ EMA «Øij¥i¥H´Â²Ä¤@½uªvÀøªº¤è¦V¨«¡C ¤½¥qµo«°T¤@¤è±¥i¥H¥¿µøÅ¥¡A¤S«Å¶Ç¡A¦ó¼Ö¦Ó¤£¬°¡C |
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·|û¡G¤p°¨10135228 µoªí®É¶¡:2017/6/26 ¤W¤È 10:15:48²Ä 2473 ½g¦^À³
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·|û¡Gwu701610136601 µoªí®É¶¡:2017/6/26 ¤W¤È 10:10:32²Ä 2472 ½g¦^À³
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ÃĵØÃÄ/AOP«Å¥¬©óEHAµoªíP1101ªvÀøPV³Ì·sÁ{§Éµ²ªG MoneyDJ·s»D 2017-06-26 08:11:38 °OªÌ ·s»D¤¤¤ß ³ø¾É ÃĵØÃÄ(6446)»Pµ¦²¤¹Ù¦ñAOP¤½¥q«Å¥¬¤T½gµoªí©ó¤µ(2017)¦~¼Ú¬w¦å²G¯fÂå¾Ç·|¦~·|(EHA)Ãö©óRopeginterferon alfa-2bªvÀø¯u©Ê¬õ¦å²y¼W¥Í¯gªº³Ì·sÁ{§É¸ÕÅçµ²ªG¡CRopeginterferon alfa-2b(P1101)¬O¤@ӳзsªº¡Bªø®Äªº¡B³æ¤@»E¤A¤G¾Jªº²ãÓi»Ä(Proline)¤zÂZ¯À¡A¹wp±N¦¨¬°¥þ²y²Ä¤@Ó³Q®Öã¥Î©óªvÀøPV¯f±w¤§¤zÂZ¯À¡CRopeginterferon alfa-2b¥Ø«e¤w¥ÑAOP¤½¥q©ó¼Ú·ù¥Ó½ÐÃÄÃÒ¤W¥«¼f®Ö¤¤¡FÃĵØÂåÃijW¹º±N¦VFDA¥Ó½ÐÃÄÃÒ¤W¥«®Öã¡A¥H¦æ¾P©ó¬ü°ê¡C ¾Ú¤½¥q´£¨Ñ¤§EHA-3520ºKn¤º®e¡APEGINVERAÁ{§É¸ÕÅç¡A´£¨Ñ¥HRopeginterferon alfa-2bªø´Áºû«ùªvÀø³Ìªø¹F6¦~(¤¤¦ì¼Æ¬°4¦~)¤§³Ì·sµ²ªG¡C¯f±w¦¨¥\¦a©ó¥§¡¬ù2¦~ªº®É¶¡¥Ñ¨â¶g¤@¾¯Âà´«¨ì§ó¤è«Kªº4¶g¤@¾¯ªø´Áºû«ù¥ÎÃĮɵ{¡C©Ò¦³29¦ì¯f±w§¡«ùÄòºû«ù¦¹ªvÀø®Éµ{¹F2¦~¡AÅã¥Ü100%ªº¥ÎÃÄ¿í±q©Ê¡C°ª¤ñ¨Òªº¦å²G¾Ç(¶W¹L80%¯f±w¹F¨ì³¡¤À©Î§¹¥þ¦å²G¾Ç¤ÏÀ³)¥H¤Î¤À¤l(³Ì°ª¦³80%¯f±w¹F¨ì³¡¤À©Î§¹¥þ¤À¤l¤ÏÀ³)¤ÏÀ³¦bÂà´«¬°¨C¥|¶g¥ÎÃĮɵ{«á«ùÄòºû«ù¡A¥B«O«ùéw(¥»¸ÕÅ礴«ùÄò¶i¦æ¤¤)¡C ¦¹¥~¡AÃĵØÃĪí¥Ü¡A¤WzºKn¤º®e¤¤¥ç»¡©ú¡A¦b4¦~ªºRopeginterferon alfa-2bªvÀø«á¡A¤j¦h¼Æ±wªÌªí²{¥i¹F¨ìJAK2V617F¬ðÅÜÅé¹ï°¸°ò¦]t²ü«ùÄò°§C¦Ü10¢H¥H¤U¡AÅã¥ÜRopeginterferon alfa-2bªvÀø¤§¯e¯f½Õ¸`¯à¤O¡F¥»¸ÕÅçµL¯e¯f¶i¤@¨B´c¤Æªºª¬ªp¥X²{¡C ¦bEHA-3556ºKn¤è±¡A¬°´î»´»ÝÀWÁc¦^¶E±µ¨üÃĪ«ª`®gªº¤wª¾t¾á¡A¶i¦æ¥Ñ¯f±w©ó®a¤¤¨ÌÓ¤H¾¯¶q»Ý¨D¦Û¦æµ¹¤©Ropeginterferon alfa-2b¤§PEN-PVÁ{§É¸ÕÅç¡C¾Ú¸ÕÅç¥D«ù¤Hµû¦ô¡A36¦ì¯f±w¤¤¨S¦³¥X²{¥ô¦ó¥i¨£ªº¯kµh©Î¨Å餣¾A¡A¤]¨S¦³¥ô¦ó¯f±w³ø§i¦]¨Ï¥Îª`®gµ§¦Ó¤Þ°_¯kµh¡C¯f±w¤ÎÂåÀø±M·~¤Hû¹ïRopeginterferon alfa-2bª`®gµ§ªº±µ¨ü«×¨}¦n¡C¾ãÓ¬ã¨s´Á¶¡¡A¦å²G¾Ç°Ñ¼Æ©MµÊŦ¤j¤p«O«ùéw¡A¥ç¥¼¥X²{¦w¥þ¤W¤§ºÃ¼{¡Cª`®gµ§¥iÅý¯f±w¦b®a¤¤¤è«K¦a¨ÌÓ¤H¾¯¶q»Ý¨D¦Û¦æ¬I¥´¡A¨Ã¹w´Á¥i¤ä«ùPV±wªÌªø´Á¨Ï¥ÎRopeginterferon alfa-2bªvÀø¤§¿í±q©Ê¡C ¦Ü©óEHA-1564ºKn¡Aµû¦ô¤ñ¸ûRopeginterferon alfa-2b»P·Rªv½¦Ån¤§¯e¯f½Õ¸`¯à¤O¡A¦bPROUD-PVÁ{§É¸ÕÅç10¦ìªk°ê¨ü¸ÕªÌ±Ú¸s¤¤¡A±´°QªvÀø¹ï©ó°©Åè³y¦å«eÅX²ÓM¤§§@¥Î¡CÁö¦b12Ó¤ë®É¡A¨âºØªvÀø¦b©PÃä¦å²G§¡¾ÉPJAK2V617F¬ðÅÜÅé¹ï°¸°ò¦]t²üªº¤U°¡A¦ý¥u¦³Ropeginterferon alfa-2b¾ÉPÅܲ§ªº°©Åè³y¦å«eÅX²ÓM¼Æ¥Ø²£¥Í¦³·N¸qªº°§C(¤¤¦ì¼Æ¤U°64¢H¡A¬Û¸û©óHUªvÀø¶È¤U°25¢H)¡Cªk°ê¤Ú¾¤¤j¾Ç±Ð±ÂKiladjian©ó³ø§i¸ÕÅçµ²ªG®Éªí¥Ü¡Aµ²ªG¶i¤@¨B¤ä«ùRopeginterferon alfa-2b¹ï©ó¯f±wªø´Á®Ä¯qªº¼ç¤O¡A¥]¬AµL´c¤Æ¦s¬¡´Á¡A¥H¤Î¨ä¿W¯Sªº¯e¯f½Õ¸`¯à¤O¡C |
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·|û¡G¤pªL10142678 µoªí®É¶¡:2017/6/26 ¤W¤È 09:03:29²Ä 2471 ½g¦^À³
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½Ð°Ñ¦Ò¥~´C·s»D½Z¡G AOP Orphan and PharmaEssentia announce latest clinical results for Ropeginterferon alfa-2b in Polycythemia Vera from 3 abstracts presented at the 22nd Congress of the European Hematology Association (EHA) in Madrid www.prnewswire.com/news-releases/aop-orphan-and-pharmaessentia-announce-latest-clinical-results-for-ropeginterferon-alfa-2b-in-polycythemia-vera-from-3-abstracts-presented-at-the-22nd-congress-of-the-european-hematology-association-eha-in-madrid-300479279.html |
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·|û¡G¤p´²¤á10028616 µoªí®É¶¡:2017/6/26 ¤W¤È 08:19:40²Ä 2470 ½g¦^À³
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money.udn.com/money/story/10161/2545797 ÃĵطsÃĸÕÅçµ²ªG¥¿± 2017-06-26 00:03 ¸gÀÙ¤é³ø °OªÌ¶À¤å©_¡þ¥x¥_³ø¾É • • ÃĵØÂåÃÄ¡]6446¡^¬Q¡]25¡^¤é¤½¥¬¤T½gµoªí©ó2017¦~¼Ú¬w¦å²G¯fÂå¾Ç·|¦~·|Ãö©óRopeginterferon alfa-2bªvÀø¯u©Ê¬õ¦å²y¼W¥Í¯gªº³Ì·sÁ{§É¸ÕÅçµ²ªG¥¿±¡A§e²{éw¡B½Õ¸`¯e¯fªº¯à¤O¡C Ropeginterferon alfa-2b§Y¬OÃĵغX¤Uªø®Ä«¬¤zÂZ¯À·sÃÄP1101¡A¹wp±N¦¨¬°¥þ²y²Ä¤@Ó³Q®Öã¥Î©óªvÀøPV¯f±w¤§¤zÂZ¯À¡C Ropeginterferon alfa-2b ¥Ø«e¤w¥ÑAOP¤½¥q©ó¼Ú·ù¥Ó½ÐÃÄÃÒ¤W¥«¼f®Ö¤¤¡FÃĵسW¹º±N¦VFDA¥Ó½ÐÃÄÃÒ¤W¥«®Öã¡A¥H¦æ¾P©ó¬ü°ê¡C Ãĵتí¥Ü¡Aªñ´Á¤½¥q©Ò´¦ÅSªºEHA-3520ºKn¤¤¡APEGINVERAÁ{§É¸ÕÅç¡A´£¨Ñ¥HRopeginterferon alfa-2bªø´Áºû«ùªvÀø³Ìªø¹F¤»¦~¡]¤¤¦ì¼Æ¬°¥|¦~¡^¤§³Ì·sµ²ªG¡A¯f±w¦¨¥\¦a©ó¥§¡¬ù¨â¦~ªº®É¶¡¥Ñ¨â©P¤@¾¯Âà´«¨ì§ó¤è«Kªº¥|©P¤@¾¯¡A¨ä¤¤¡A©Ò¦³29¦ì¯f±w§¡«ùÄòºû«ù¦¹ªvÀø®Éµ{¹F¨â¦~¡AÅã¥Ü¤F100%ªº¥ÎÃÄ¿í±q©Ê¡A¸Ó¸ÕÅç«ùÄò¶i¦æ¤¤¡AµL¯e¯f¶i¤@¨B´c¤Æªºª¬ªp¥X²{¡C |
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