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¤§«e¤À¨É¹LKeytruda¾ÌµÛ61¤H¦¸±Ú¸sªº41%¤ÏÀ³²v¨ú±oÃÄÃÒ ³oÓÁ{§É³]p«Ü¦³½ì¡A«D±`ȱo¤j®a°Ñ¦Ò¡A§Ú²³æ´£¤@¤U ®Ú¾Ú¥h¦~12¤ëµoªí¦bThe Lancetª¾¦WÂå¾Ç´Á¥Zªº³¡¤À¸ê®Æ(n¥I31.5¬üª÷¤~¯à¬Ý¥þ¤å) www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(15)01281-7.pdf Ãþ¦üªº¤å¦r¦bESMO Asia 2015¤]¥i¥H¬Ý¨ì ¤J¿ï±ø¥ó¤§¤@¬OPD-L1ªí²{²v¥²¶·¤j©ó1% ³oÓÁ{§Éªºprimary endpoints¬O¡G overall survival and progression-free survival both in the total population and in patients with PD-L1 expression on at least 50% of tumour cells ¬Ý²M·¡¨Ó¡GPD-L1ªí²{²v¶W¹L50%ªº¤H½s¦¨¤@²Õ¡A©Ò¥H822°e³ø§i®É¥i¯à¥i¥H¥Î§ÜÅé¶qX¿......
Á{§Éµo²{¡APD-L1ªí²{²v¶W¹L50%ªº¤H...... Among patients with at least 50% of tumour cells expressing PD-L1, overall survival was significantly longer with pembrolizumab 2 mg/kg than with docetaxel (median 14¡P9 months vs 8¡P2 months; HR 0¡P54, 95% CI 0¡P38¡V0¡P77; p=0¡P0002) and with pembrolizumab 10 mg/kg than with docetaxel (17¡P3 months vs 8¡P2 months; 0¡P50, 0¡P36¡V0¡P70; p<0¡P0001). Likewise, for this patient population, progression-free survival was significantly longer with pembrolizumab 2 mg/kg than with docetaxel (median 5¡P0 months vs 4¡P1 months; HR 0¡P59, 95% CI 0¡P44¡V0¡P78; p=0¡P0001) and with pembrolizumab 10 mg/kg than with docetaxel (5¡P2 months vs 4¡P1 months; 0¡P59, 0¡P45¡V0¡P78; p<0¡P0001).
ÁÙ¦³¡G³oÓÁ{§É¸ÕÅç¬O¤@ª½¥´¡A¥´¨ì¥X²{µLªk§Ô¨üªº¬r©Ê¡A¥´¨ì¥X²{«æ³t´c¤Æ²{¶H¡A¥´¨ì4-6¶g«á¦A¦¸¼v¹³½T»{PD¡A¥´¨ìperformance status¤U°¡A¥H¤W³]p¥iÁ×§K®û¼í»~§P¡A¤£·|ºÃ¦üPD´N¥ß¨è°h¥XÁ{§É
FDAµ¹ÃÄÃÒ²z¥Ñ¡GPD-L1ªí²{²v¶W¹L50%ªº¯f±w¤ÏÀ³²v¬O41%...... The effectiveness of Keytruda for this use was demonstrated in a subgroup of 61 patients enrolled within a larger multicenter, open-label, multi-part study.This subgroup also had PD-L1 positive tumors based on the results of the 22C3 pharmDx diagnostic test.Tumors shrank in 41 percent of patients treated with Keytruda and the effect lasted between 2.1 and 9.1 months
¤×¨ä±wªÌn¥´¥|°w¤~ª¾¹D¦³¨S¦³®Ä?³o·|¤£·|¿ù¥¢ªvÀø¨}¾÷?¤SÂå¥Í·|¿ï³o¼ËÀøªk? ¦]¬°¤£ª¾¹D½Ö·|²£¥Í§ÜÅé¤Sn¥ýªá¶O¤@µ§¬°¼Æ¤£¤ÖÂåÃĶO¸òÀø´Á........... Keytruda¥é³æ¦³ÃöªÍÀùªº¨Ï¥Î»¡©ú¡G patients with metastatic NSCLC whose tumors express PD-L1 as determined by an FDA-approved test FDA®Ö㻲§UÀË´úPD-L1ªí²{²v´ú±otumor proportion score of greater than or equal to 50% tumor cells ¤d¬D¸U¿ïPD-L1ªí²{²vn¶W¹L50%ªº¤H¥´¤U¥h´N«OÃÒ¦³¥Î¶Ü¡HNO¡I
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TFDA: °ê¤ºªº»¡ªk: ®Ú¾Ú½Ã¸pÂå¦r²Ä0910014830¸¹¨ç¤§»¡©ú»P¸ÑÄÀ¡GÃÄ«~¡u¥é³æ®Öã¾AÀ³¯g¥~ªº¨Ï¥Î¡vì«h¦p¤U¡G(1)»Ý°ò©óªvÀø¯e¯fªº»Ýn¡]¥¿·í²z¥Ñ¡^¡A(2)»Ý²Å¦XÂå¾Çì²z¤ÎÁ{§ÉÃIJz¡]¦X²z¨Ï¥Î¡^¡A(3)À³¾Ú¹ê§iª¾¯f¤H¡A(4)¤£±o¹H¤ÏÃÄ«~¨Ï¥Î·í®É¡A¤wª¾ªº¡B¨ã¤½«H¤OªºÂå¾Ç¤åÄm¡A(5)¥ÎÃÄÀ³ºÉ¶q¥H³æ¤è¬°¥D¡A¦p¦P®É¨Ï¥Î¦hºØÃÄ«~¡AÀ³¯S§Oª`·N¨äºî¦X¨Ï¥ÎªºÀø®Ä¡BÃÄ«~¥æ¤¬§@¥Î©Î¤£¨}¤ÏÀ³µ¥°ÝÃD¡C (http://blog.xuite.net/yahoo_32454/twblog/132639699-¥é³æ®Öã¾AÀ³¯g¥~ªº¨Ï¥Î(Off-label+use)Û²z·Ç«h)
FDA: (http://www.fda.gov/ForPatients/Other/OffLabel/default.htm ) Off-Label Use of Approved Drugs :
Used for a different disease or medical condition. Given in a different way (such as by a different route). Given in a different dose.
Off-label is also called "non-approved" or "unapproved" use of a drug. New uses for these drugs may have been found, and often medical evidence supports the new use. But the makers of the drugs have not put them through the formal, lengthy, and often costly studies required by FDA to officially approve the drug for new uses.
What Questions Should I Ask my Healthcare Provider About Off-Label Use? If you and your Healthcare Provider are considering off-label use of an approved drug, consider asking these questions before deciding whether it is right for you. Is there information available to support the off-label use of this drug to treat my condition?(Ãþ¦ü¤W±¤§²Ä¥|±ø) Is this off-label drug likely to work better than an approved drug? (¤ñ¨ä¥LÃħó¦n) What are the risks and benefits of off-label treatment with this drug?( ®Ä¯q·ÀIµû¦ô) Will my health insurance cover off-label treatment with this drug? («OÀIµ¹¥I...)
Á`µ²¬Ý°_¨Ó...¬O¥H¦h¶µ«ü¼Ð³Ì«á¬ÝÂå¥Í¤§«H¤ßµ{«×¨Ó¶}³æ(¥BnÁ×§K«á¿ò¯g...ÂåÀøªÈ¯É) Áp¦X¥ÎÃĽä¤ñ¸û¤j, ¤@¯ë¨Ó»¡n°µ¹êÅç...
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