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Cliff ¤j®¦¼wªº¥»»â , ¥O¤H¹Ä¬°Æ[¤î °¨¤ó®a±Úªº±M§Q¤å¥ó¡B¹êÅç«Ç,³£°k¤£¹LÁo¿oºø±Kªº«äºû , ÆF¥©ªº¤â , ¥H¤Î¼s¯Ç¤K¤èªº¦Õ ÁÙ¦³¹ïCFDA®Öã822ªºÁ{§ÉºÃ¼{¡A¤½¥q¥Î[«¤j°T®§]¦^À³ÄÀºÃ Åý¤j®a©M¤pªº³£¶}¤F²´¬É ªá¤F°²´Áªº³¡¤À®É¶¡´M§ä ¡B®ø¤Æ¸Óµ¥¤½¶}±M§Q¤å¥ó ¤º®e¦p¤Ñ®Ñ ¡A¥u¯à²q§r! °¨¤ó®a±Úªº±M§Q¤å¥ó¼ÐÃD [ ANTIBODIES AGAINST IMMUNOGENIC GLYCOPEPTIDES, COMPOSITION COMPRISING THE SAME AND USE THEREOF ] «ÂI©Î¦b§ÜÅ骺²Õ¦¨¥÷©M¥Î³~ ¦b [Claims ] ¥u´£¤Î 1.The antibody is a chimeric or humanized antibody. (´O¦X©Î¤H·½¤Æ§ÜÅé) 2.§ÜÅé«Ãì(heavy chain) »´Ãì(light chain)ªº²Õ¦X ¡Kµ¥ ¨Ã¥¼¦p¦b [ Description ] ¤¤©Ò´£ªº GH´O¦X©Î¤H·½¤Æ§ÜÅ骺»s³Æ ¥B´£¨ì¿Ä¦X½F¤Î¾½µßÅé§Þ³N [0061] In one embodiment, the isolated anti-Globo H antibody is a monocloncal antibody.Monoclonal antibodies to Globo H can be made according to knowledge and skill in the art. For example, it can be made by injecting test subjects with Globo H conjugate of the inventionand then isolating hybridomas expressing antibodies having the desired sequence or functional characteristics. [ 0063 ] In a further embodiment, antibodies or antibody fragments can be isolated from antibody phage libraries generated using the conventional techniques known in the art; for example, the isolation of murine and human antibodies, respectively, using phage libraries.Subsequent publications describe the production of high affinity (nM range) human antibodies by chain shuffling, as well as combinatorial infection and in vivo recombination as a strategy for constructing very large phage libraries. Thus, these techniques are viable alternatives to traditional monoclonal antibody hybridoma techniques for isolation of monoclonal antibodies. ²q´ú¨ä±M§Q«OÅ@¦b§ÜÅé²Õ¦¨¡A¦Ó¤£¦b»s³Æ? ©Î³\´N¦pPD-1 ¡B PD-L1§ÜÅé¡A¦Ê®aª§»ï ¡A¦UÃļt³£¦bµo®i ¡A ¦ý§ÜÅé»´¡B«Ãì²Õ¦X¦³©Ò¤£¦P ¡A ³y¦¨Àø®Ä°Æ§@¥Î¦U¦³®t²§ ¸Ü»¡¦^¯E¹© ¯E¹©ªº§ÜÅé©M°¨¤ó®a±Úªº¤ñ¸û¡A±EÀu? ¤p§Ì¤£ª¾¹D ¦ý¦bÄvª§¹Lµ{¤¤ °¨¤ó®a±Ú¥Îªº [0089] Adult female C57BL/6 mice were immunized by subcutaneous injection with 6 £gg of Globo H-PADRE glycopeptides wherein PARDE represents a polypeptide of AKXVAAWTLKAAA (SEQ ID NO:238), and 50 £gg of complete Freund¡¦s adjuvant (CFA; from Sigma). ¦³µL¯A¤Î«IÅv? ¤pªº¤]¤£ª¾¹D ¨ó½Õ¦X§@ ©Î¶R¤J(±ÂÅv)¬Oӿﶵ? pµe¤¤ªº¶R¶i¶ê²»ªÑÅv ¡A ©Î³\´N¬°¤F¦]À³§ÜÅé§ï¨}¤Î¤j¶q²¤Æ»s³yªº·Ç³Æ¡A¦ýY§ï¬°¥þ¤H·½§ÜÅé¡A¤§«eªºÁ{§É«e¸ÕÅç¬O¤£¬O¶·«·s¨Ó¹L? ©Î¥u¦³»s³Æ¯à§Y®É¬£¤W¥Î³õ? ¤½¥qª¾¹D¦¹¨Æ¤w¸g³o»ò¤[¤F¡A ¥u¦³¶ê²»³oӰʧ@ ©M°¨¤ó®a±Ú¬O§_¤]¨ó½Õ¦n¤F©O?!ÁÙ¬O»{¬°«Â¯Ù¤£¤j? §_«h·íªìªº§Z±_Àù¤G´Á¸ÕÅç ¡A ¯uªº´NÅܦ¨¶µ²ø»R¼C ¡A ·N¤£¦b¨K¤½¤F?! µM¦Ó°²¦p¤½¥q¹ï888ªº¦w¥þ©Ê¡BÀø®Ä¦³«H¤ß¡A ©Î³\¦bÁ{§É¤W¡A ¤]À³´ÂORR¡B DOR¡BPFSµ¥¥DnÀø®Ä«ü¼Ð¨Ó³]p¡A¬Æ©ÎI / II ´Á¨ÖµÛ°µ ´Á¬D¾Ô¤@½uÃĪ«¡A¨Ã¥[§ÖÁ{§É¶iµ{ ¡A¾¨§Öº¡¨¬±wªÌ»Ý¨D ¥t¥~¡ACFDA¹ï©ó822¥Ó½ÐÁ{§É¤G´Á¡A Âର®ÖãÁ{§É¤T´Á¡A ¤]ºâ¬O¹ï©ì©µ822ªº¸ÉÀv¡A ¤£µL¶ë¯Î¥¢°¨¤§·N 2017©Î·|¬O¯E¹©¦U¶µ¶iµ{pµeªº§e²{¦~¡A´Á«Ý¦³¥X¤H·Nªíªºµ²ªG ¤S²q¤S´Á«Ý¡A¦h©Ò»~ÂÕ¡A¶È¨Ñ°Ñ¦Ò ¡A¨Ã½Ð«ü¥¿ ¡AÁÂÁÂ! |
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105/04/30 104¦~¦~³ø ¡u¦ÓOBI-822 «e¶i¤¤°êªºÁ{§É¤T´Á¸ÕÅç¡A¥Ø«e¥¿»P¤¤°ê°ê®a¹«~ÃÄ«~ºÊ·þºÞ²zÁ`§½(CFDA)®i¶}±K¤Á°Q½×¡A±N®Ú¾Ú¦¹¦¸¸Ñª¼µ²ªG¡A³W¹º·sªºÁ{§É¸ÕÅç³]p¡C¡v 105/06/27 104¦~Àç·~³ø§i®Ñ ¡uOBI-822 «e¶i¤¤°êÁ{§É¸ÕÅç¡A¥Ø«e¤w»P¤¤°ê°ê®a¹«~ÃÄ«~ºÊ·þºÞ²zÁ`§½¡]CFDA¡^®i¶}±K¤Á°Q½×¡A¥Ñ©óì°epµe¦¬®×¤w§¹¦¨¡A¹wp2016¦~8¤ë«e®Ú¾Ú¦¹¦¸¸Ñª¼µ²ªG¡A³WµeÁ{§É¸ÕÅç³]p¡C¡v 105/12/27 µo¦æû¤u»{ªÑÅv¾ÌÃÒ¤½¶}»¡©ú®Ñ ¨S´£¨ì¡C 106/01/25 «¤j°T®§ ¡u¥»¤½¥q¨ÅÀùªvÀø©Ê¬Ì](OBI-822)©ó101¦~12¤ë25¤é¦V¤¤°ê°ê®a¹«~ÃÄ«~ºÊ·þºÞ²z§½¥Ó½Ð¡¨¶i¤fªvÀø¥Î¥Íª«Á{§É¸ÕÅ硨¤§®Öã¡A104¦~8¤ë4¤é¤¤°ê°ê®a¹«~ÃÄ«~ºÊ·þºÞ²zÁ`§½ÃĪ«¼fµû¤¤¤ß¥¿¦¡¼f¬d¥»®×¡A106¦~1¤ë16¤é§å㥻«~¦b¤¤°ê®i¶}²Ä¤T´ÁÁ{§É¸ÕÅç¡A¥»¤½¥q©ó106¦~1¤ë24¤é¨ú±o¥¿¦¡®Öã¤å¥ó¡C¡v ¡u¹wp¶i¦æ¤§©Ò¦³¬ãµo¶¥¬q¡G¥Ø«e¹wp¦b¨È¬w°õ¦æ¦h¤¤¤ß·sÃIJĤT´ÁÁ{§É¸ÕÅç¡C¡v ¦]¦¹±À´úèÀò¤¤°êÃĺʧ½§å㪺²Ä¤T´ÁÁ{§É¸ÕÅç¥i¯à¬°ÂÂp¹º¤º®e¡A¤½¥q©ú½T´£¨ì¡u¹wp2016¦~8¤ë¡]105¦~8¤ë¡^«e®Ú¾Ú¦¹¦¸¸Ñª¼µ²ªG¡A³WµeÁ{§É¸ÕÅç³]p¡C¡v¡A¦Ó¤¤°êÃĺʧ½¦¦b¡u104¦~8¤ë4¤é¤¤°ê°ê®a¹«~ÃÄ«~ºÊ·þºÞ²zÁ`§½ÃĪ«¼fµû¤¤¤ß¥¿¦¡¼f¬d¥»®×¡v¡A¥i¯à¦b¹ï©¤¶}©l¼f¤F¤@¦~«á¡A¤½¥q®Ú¾Ú¦¹¦¸¸Ñª¼µ²ªG¦A°e¤W×qª©ªºpµe®ÑÄò¼f¶Ü¡H ¬°¤°»ò¤£¬O»¡±µ¤U¨Óªº¶i«×¬O¡u¡K¹wp¦b¤¤°ê°õ¦æ¡K¡v¡H¦Ó¬O¡u¡K¦b¨È¬w°õ¦æ¡K¡v¡H ¬O§_¹wp2016¦~8¤ë«e®Ú¾Ú¦¹¦¸¸Ñª¼µ²ªG¡A³Wµe¡u¨È¬w¡v¦h¤¤¤ß·sÃIJĤT´ÁÁ{§É¸ÕÅç³]p¡H 106/01/25 ¤µ¤Ñ®É³ø³ø¾É¡]www.chinatimes.com/realtimenews/20170125003435-260410¡^ ¡u¯E¹©(4174)¨ÅÀù·sÃÄAdagloxad Simolenin(OBI-822¡A¤SºÙOPT-822)Àò¤¤°ê¤j³°³q¹L¶i¦æ²Ä¤T´ÁÁ{§É¸ÕÅç¡C¯E¹©¬Q¤é¤U¤È±µÀò¤¤°ê°ê®a¹«~ÃÄ«~ºÊ·þºÞ²zÁ`§½(CFDA) Á{§É¸ÕÅç§å¥ó¡A¥¿¦¡³q¹L¨ÅÀù·sÃÄAdagloxad Simolenin (OBI-822¡A¤SºÙOPT-822)Á{§É¸ÕÅç¥Ó½Ð¡A®i¶}³o¶µ¨È¬w¦h¤¤¤ß²Ä¤T´ÁÁ{§É¸ÕÅç¡C ¯E¹©ªí¥Ü¡ACFDA©Ò®Ö§åªºOBI-822¸ÕÅç«Y±ÄÀH¾÷¡BÂùª¼¡B¦w¼¢¾¯¹ï·Ó¤è¦¡¶i¦æ¡A¥H¿E¯À¨üÅé(hormone receptor¡AHr¡^¶§©Ê¡BHer-2³±©ÊªºÂಾ©Ê¨ÅÀù¯f¤H¬°¹ï¶H¡A¦ôp¦¹¤@¦¸±Ú¸s¬ù¦û©Ò¦³¨ÅÀù¯f¤H60%¥ª¥k¡A¹wp¦¬®×414¤H¡A±N©ó24Ӥ맹¦¨¦¬®×¥Ø¼Ð¡C ¥xÆW¯E¹©¦b2012¦~12¤ë25¤é¦VCFDA´£¥X¤HÅéÁ{§É¸ÕÅç¥Ó½Ð(IND)¡A¸Ópµe¥ç©ó·í¦~Àò¥xÆW¹«~ÃĪ«ºÞ²z¸p¡]TFDA¡^µû¿ï¬°º§å¡u¨â©¤ÃÄ«~¬ãµo¦X§@±M®×¸Õ¿ìpµe¡v¤Ó·sÃıMÃD¤§¤@¡AìÀÀ¦b¨â©¤2010¦~©Òñqªº¡u®ü®l¨â©¤ÂåÃĽåͦX§@¨óij¡v¬[ºc¤U¡A³z¹L¦¹¤@¸Õ¿ìpµe±À°Ê¨â©¤Á{§É¸ÕÅç¦X§@»P¥æ¬y¡A¥H¾®»EÂù¤è¬ã¨s¯à¶q¡A´î¤Ö«½Æ¹êÅç¡A¨ó¦X¨â©¤·sÃĬãµo³W½d¡C±¤³o¶µ±MÃDpµe«á¨Ó¨Ã¥¼¸¨¹ê¡A¯E¹©±Æ¶¤µ¥Ô¼f§å¥|¦~«á¡ACFDAªºÃĪ«¼fµû¤¤¤ß©ó2015¦~8¤ë4¤é¥¿¦¡¼f¬d¥»®×¡A¦Ó©ó¤µ¦~1¤ë16¤é³q¹L¡A¬Q¤Ñ¨ú±o¥¿¦¡®Öã¤å¥ó¡C¨Ì³W©w¡A¶·©ó§åã¤é°_¤T¦~¤º¹ê¬I³q¹L¼f§åªºÁ{§É¸ÕÅç¡C¡v ¥Ñ¤µ¤Ñ¤½¥qµo§Gªº«°T»P®É³ø³ø¾Éªº¤º®e¡A¤´µM¤£²M·¡¥¼¨Ón¹ê¬Iªº¤¤°ê¤T´Á¸ÕÅçpµe¬O¤£¬O´N¬OèÀò®Ö㪺³oÓp¹º¡C¦³¤@ÂIµïµ·°¨¸ñµo²{®É³ø©Ò¥Îªº¬O¡uOPT-822¡v¡A³o¬Oè¸Ñª¼ªº¥xÆW¤T´Á¸ÕÅçpµe¶i¦æ®Éªº¨ºÓ¦~¥N·|¨Ï¥ÎªººÙ©I¡F¨ºÓp¹º¦WºÙ¤´¥ÎOPT-822-001¡A©Ò¥H¤@¦~«á¦V¤¤°ê¥Ó½Ð¤T´Á¸ÕÅç¤]ªu¥ÎOPT-822«D±`¦X²z¡A¦ýÀHµÛ¸ÕÅç«á´Á¸g¹L¸Ñª¼¨ì²{¦b¡A¦´N¤@P§ïºÙ¬°OBI-822¡A¤@¦p¤µ¤Ñªº«°T¤º®e¤£¦A¥X²{OPT-822¦r²´¡C ¦pªG¥¼¨Ó¬On¶i¦æ·í¦~¥Ó½Ðªº¥¼×§ïªºÂÂp¹º¡A¨º¸ÕÅ窺µ²ªG·|»P¥h¦~¸Ñª¼ªºµ²ªG¦³¦ó®t§O¡H |
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«z ¡I ¤]¦³Á{§É¤T´Áªº®×¨Ò ¤Ñ©R¤jªº³o½g¤å³¹¡A¥¿¦n»¡©úFDA ªº¼u©Ê¡A¤]¬°¤U¦CºK¿ý§@¤Fª`¸Ñ ©Î³\¤½¥q¦bµ¥OS¦¨¼ô¦A°e¥ó§a¡H¡I Applying the Breakthrough Therapy Designation Criteria in Practice In considering a request for BTD, FDA relies on three primary considerations: 1) the quantity and quality of the clinical evidence being submitted in a designation request; 2) the available therapies that the drug is being compared to; and 3) the magnitude of treatment effect shown. Although these considerations are clear, it is difficult to define a single threshold that a therapy must meet in order to receive the designation. Requests for breakthrough therapy designation cover a wide range of therapeutic areas, and although the Expedited Programs guidance recommends that requests be submitted no later than end-of-phase 2, requests may be submitted at different stages of drug development with quite different levels of supporting evidence. Requests can also differ significantly in terms of the amount of clinical trial data included (i.e., differences in sample size, phase of drug development), trial design (i.e., choice of endpoints, single-arm versus, randomized controlled), and trial results (i.e., the magnitude of treatment effect size seen.) ¡]¸`¿ý¦Ûhttp://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM447165.pdf¡^ US FDA Expedited Programs and Expanded Access (BTDªºÂ²n»¡©ú¡^ http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2016/12/WC500218404.pdf Timeline for FDA response: Within 60 calendar days ¡]p.17/37) |
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2016¦~12¤ëè¥Xª©ªº¡u2015¥ø·~ªÀ·|³d¥ô³ø§i®Ñ¡v¡A¨C¨â¦~·|¥Xª©¤@¦¸¡C¡]www.obipharma.com/userfiles/file/obi_csr2015_1216.pdf ¡^ 1.page. 31/64 ¡u2.2.2 OBI-833 ·s¥@¥NÀù¯gªvÀø©Ê¬Ì]¡v¡G ùر´£¨ìGlobo H -DT¥sOBI-833¡A¥[¤J¦õ¾¯OBI-821¡A²V¦X¦¨¬°OBI-833/OBI-821¬Ì]¡C YOBI-833²V¦X¤¤¬ã°|¬ãµoªº¦õ¾¯C34(©R¦W¬°OBI-834)¡A«h¦¨¬°OBI-833/OBI-834¬Ì]¡C ³o¬O²Ä¤@¦¸¥¿¦¡Åª¨ì©x¤è¦p¦¹ªººÙ©I¡A³o¨âÓ¬Ì]ªº¥¿¦¡¦WºÙÀ³¸Ó¬O¡GOBI-833/OBI-821¬Ì]»POBI-833/OBI-834¬Ì]¡C¡]«eªÌ¬O¤½¥q²{¦æª©ªº833¡A«áªÌ¬O°|ªøª©ªº833¡^ ¤]´N¬O»¡¦pªG¥u»¡834¡A¨ä¹ê¥u¬O«üC34³oÓ¦õ¾¯¦Ó¤w¡A¤£¬O¾ãÓ¬Ì]¥sOBI-834¡C 2.page. 33/64¡F ¡u2.2.5 OBI-888¥HGlobo H¬°¼Ð¹vªºÀù¯g³Q°Ê§K¬ÌÀøªk¡v¡G ¡u°w¹ïÀù¯g¯f¤H¤¤¡A¦]¬°§K¬Ì¨t²Î¸ûÁ¡®z¦ÓµLªk¨Ï¥Î¬Ì]¹F¨ìªvÀø®ÄªGªº¯f¤H±Ú¸s¡A¥iª½±µ¥H³æ®è§ÜÅé¶i¦æªvÀø¡COBI-888§Y¬O°w¹ïGlobo¨t¦CÁÞ¬°¼Ðªº³]pªº³Q°Ê¦¡§K¬ÌÀøªk³æ®è§ÜÅé¡A¬°¥Ø«eÀù¯gªvÀø¨Ï¥Î³Ì¬°¼sªxªº¼Ð¹vªvÀø¤èªk¡A°w¹ïÀù²ÓMªí²{Globo H¥B¹ï¥D°Ê§K¬ÌÀøªkªvÀø¤ÏÀ³¸û®zªº¯f¤H¡A´£¨Ñ¦¹¤@¼Ð¹vªvÀøªº¿ï¾Ü¡A¬°¨ÅÀù¯f¤H´£¨Ñ§ó¥þ±ªºªvÀø¡C ºI¦Ü2015¦~4¤ë©³¡A¥»¤½¥q¬ãµo¹Î¶¤¤wµo®i¥X¾A¦Xµo®iªºÃĪ«§ÜÅéµ²ºc§Ç¦C¡A§¹¦¨¸Ó§Ç¦C³ÌÀu¤Æ¡A¦P®É©ó2015¦~4¤ë´£¥X¬ü°ê±M§Q¤ÎPCT°ê»Ú±M§Q¥Ó½Ð¡CºI¦Ü2016¦~4¤ë©³¡A¤w§¹¦¨µU¤lªº³æ¤@¾¯¶q¬r©Ê¸ÕÅç¡A¨Ã¥¼µo²{¥ô¦óÁ{§É¯gª¬¡F¨Ã¤w¿ï¥X°ª²£¶qªº§ÜÅé²ÓM®è¡A¥¿¦b¶i¦æ¶q²£¤¤¡C¥¼¨Ó±N©óÁ{§É¸ÕÅ礤±´¯ÁÃĪ«¦w¥þ©Ê¤Î¦hºØ¤W¥ÖÀù¤¤ªºÀø®Ä¡C¡v ¤£¸Ñ¡H ¨ä¤¤¡u¨Ã¤w¿ï¥X°ª²£¶qªº§ÜÅé²ÓM®è¡A¥¿¦b¶i¦æ¶q²£¤¤¡C¡v³o¥y¸Ü©Ò«üªº¬O¤w±qµU¤l¨¤W¨ú±o°ª²£¶qªº§ÜÅé²ÓM®è¶Ü¡H¦pªG¬O¡A¬°¦ón±qµU¤l¨¤W¨ú±o°ª²£¶qªº§ÜÅé²ÓM®è¨Ó¶i¦æ¶q²£¡H ¦Ó2015¦~4¤ë10¤é¦V¬ü°ê±M§Q¤ÎPCT°ê»Ú±M§Q¥Ó½Ðªº±M§Q¤å¥ó¡]WO2015/157/629¡^¡G ÃD¥Ø¡GANTIBODIES, PHARMACEUTICAL COMPOSITIONS AND USES THEREOF ¥Ó½Ð¤H¡GOBI PHARMA INC µo©ú¤H¡GLAI, Jiann-Shiun; (TW)¡B¡K¡K¡C page. 14/80 ¡u¡£0055¡¤The humanized antibody of the present invention is an antibody from a non-human species where the amino acid sequence in the non-antigen binding regions¡]and / or the antigen-binding regions¡^has been altered so that the antibody more closely resembles a human antibody while retaining its original binding ability. ¡v¥iª¾¦¹µo©ú¨Ó¦Û«D¤H·½§ÜÅé¡CÄ~ÄòŪ¤U¥h¥iª¾³o¬O¤@ÓÃö©ó¿Ä¦X½F§Þ³N¨Ó¬ãµo³æ®è§ÜÅ骺±M§Q¥Ó½Ð¡C ¬d¡uwww.sgjh.tc.edu.tw/TeachWeb/hereditary/BIO_TECH/mono_antibody.htm¡v¡G ¡u¡K¡K¤HÃþªº³æ®è§ÜÅé¥H²ÓM¿Ä¦X½Fªº¤è¦¡¬Û·í§xÃø¡K¡K¡v¡A¾Ú¤F¸Ñ¥H²ÓM¿Ä¦X½F§Þ³N¨Ó¬ãµo³æ®è§ÜÅé¤@¯ë¬O±q¹«©Î¨ß·½¡A§Y«D¤H·½©Ê¨Ó·½¡A«áÄò¤´¶·¸g¹L¤H·½¤Æªº¨BÆJ¤~¯à²Å¦X¤H¥Î¡F¦ýY¬O¬Y¤H±q¬I¥´822©Ò²£¥Íªº§ÜÅé¡A¨ú±o¤H·½ªº§ÜÅé°ò¦]¡A¦AÂÇphage display§Þ³N¡A«K¥i¸û§ÖÀò±o¯Â¤H·½GH³æ®è§ÜÅé¡C µª®×©I¤§±ý¥X¡C ¦A¬Ý³oÓ¡K¡K 2015¦~3¤ë19¤é¦VPCT°ê»Ú±M§Q¥Ó½Ðªº±M§Q¤å¥ó¡]WO/2015/143123¡^¡G¡]¥Ó½Ð¤é´Á¤ñ2015¦~4¤ë10¤éÁÙ¦¤F¤T¶g¡^ ÃD¥Ø¡GANTIBODIES AGAINST IMMUNOGENIC GLYCOPEPTIDES, COMPOSITION COMPRISING THE SAME AND USE THEREOF ¥Ó½Ð¤H¡GMACKAY MEDICAL FOUNDATION THE PRESBYTERIAN CHURCH IN TAIWAN MACKAY MEMORIAL HOSPITAL µo©ú¤H¡GCHANG, Chih-long; (TW)¡BWU, Chao-chih; (TW)¡C ¦ó³\¤H¤]¡H±iXX¡B§d¬LX¡C ¡uwww.mmh.org.tw/research/MRDLab_3728.html ¡v ¤G¡B®Ö¤ß§Þ³N 1.¡K¡K 2.¯S©w§Þ³N¤ÀÂ÷¤HÃþÀù¯g·F²ÓM¡A«Ø¥ß¤p¹«Àù¯g·F²ÓM¥¥x¤Î¹B¥Î ¡C 3.¾½µßÅéÐ`肽®w¤Î³æ®è§ÜÅé®w«Ø¥ß¤Î¹B¥Î¡C 4.³æ®è§ÜÅéµo®i»P³Æ»s µo®i¨ã¦³ªýÂ_©Î¬¡¤Æ¯S©w²ÓMªí±³J¥Õ¤§³æ®è§ÜÅé¥Î¥H¨Ñ¯S©w¥Íª«¬¡©Ê¤ÀªR¡C 5.¡K¡K ¸g¦Ñ¥v¤j¤j´£¿ô¡A³o¨âӥӽФ¤ªº±M§Q³£¬OWO¦rÀY¡A¤£ºâ¯u¥¿¤w¸g¨ú±o¥ô¦ó¤@°êªº±M§Q¡A¥i¯à¥u¬O¸Õ¸Õ¤ô·Å¦Ó¤w¡C¡]www.patent-tutorial.net/website/content/forum/1570 ¡^ ¶µ²ø»R¼C¡A·N¤£¦b¨K¤½¡H ®£«D¶µ²ø¡A¤D¥q°¨¬L¤]¡I |
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Dear all Somebody had posted the 833 trial on her facebook. Thanks |
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¥xÁÞ¤j ½¤F¤@°ï¡A³ºµM§ä¤£¨ì¥H«eªº¸Ô²Ó¸ê®Æ ²{¦b¥u¯à´N°O¾Ð©Ò¤Î¦^·Q MBCªº5¦~¦s¬¡²v¬ù¬°25% ©Ò¥H¹ï·Ó²Õ5¦~³Ì¤j¨Æ¥ó¼Æ¬ù¬°93¤H¡]124x75%)¡A³oӼƦb¹êÅç²Õ·|¹F¼Ðªº«O¦u°t¹ï¼Æ¬ù120¤H ¤]´N¬O»¡¡A·í¹êÅç²Õ¨Æ¥ó¼Æ¶W¹L120¤H¡A´N¦MÀI¤F¡A°£«D¹ï·Ó²Õ¨Æ¥ó¼Æ¤]¯à¶W¹L93¤H ¤S®³¥t¤@²Õ°t¹ï¡]90¡A75¡^¡A³o¬O±N´Á¤¤¸Ñª¼IgG<1:40ªº¬ù¦ô¨Æ¥ó¼Æ¡]¬ù17¤H¡^¦©°£«á¡]50-17=33¡^ ¨ä¨â²Õªº¨Æ¥óµo¥Í¤ñ¬°33:35¡A¨ú1:1¡A§@¬°¨â²Õ¦b´Á¤¤¸Ñª¼«áªº¨Æ¥óµo¥Í¤ñ¨Ò¡A§Y¨â²Õ¦Uµo¥Í40¥óªº°t¹ï¡A³o²Õ°t¹ï¤]¥i¹F¼Ð ·íµM¡]60¡A60¡^¡F¡]70¡A70¡^¡F¡]80¡A80¡^¡F¡]90¡A90¡^´N§ó¤£¦b¸Ü¤U¤F ©Ò¥H¤p§Ì»{¬°°£«D¨â²Õ©Ô±o«Ü¶}¡]§Y¨C¤ë¨Æ¥ó¼Æè¶}©l¥Ã¡A«á¨Óº¥ÁY¡A³o©Î³\ªí¥Ü«á¨Ó¹êÅç²Õ¨Æ¥ó¼ÆÁͽw¡^ §_«h¤½¥qÀ³·|µ¥«Ý¨Æ¥ó¼Æ¨Ó¨ì¤@Ó«O¦uªºÂI¦A´Á¥½¸Ñª¼¡A³o¼Ë´N ¬Û¹ï¦w¥þ³\¦h¡A§K±o¦Y§Ö§Ë¯}¸J¡A±o¤£Àv¥¢¤F ¥H¤W©ÒÁ|ªº°t¹ï¡A¨äpÈ·|¤p©ó0.05¡AHRªºCI¤£§t¬A1¡Apower·|¤j©ó90% ¦ý¯u¥¿¶}¼úªº°t¹ï·|¦p¦ó¡A°ß«Ý¤½¥qµo¥¬ ¶È¨Ñ°Ñ¦Ò¡Aµü¤£¹F·N³B¡A½Ð½Ì¡AÁÂÁ¡I |
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½Ð±Ð²q·Q¤j Á`¨Æ¥ó¼Æ¦b180¥H¤W¡A¤~¦³¸Ñª¼¥i¯à(¥HpÈ¡BHR¤Îpower±À¦ô) ¨ä¤¤power ¬O¦Ò¼{ > 90 ? ©Î power > 80 ¤]¥i¥H? ¤£ª¾OBI822 power q 80 ¥H¤W ©Î90¥H¤W? ¦ppowern90¥H¤W ªº½T¨Æ¥ó¼Æ¬ùn175 - 180 ¥ª¥k ( 2015 ¦~10¤ë¬O85¤H ¹êÅç²Õ50 ¹ï·Ó²Õ35 ) ¦ppowerq80¥H¤W¨Æ¥ó¼Æ¬ùn 120 - 170 ¥ª¥k³£¦³¾÷·| |
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·|û¡G²q·Q10136148 µoªí®É¶¡:2017/1/19 ¤U¤È 02:40:49²Ä 3065 ½g¦^À³
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¤Ñ©R¤j ¥xÁÞ¤j ¥h¦~¡A¤p§Ì´¿¸ß°Ý¤½¥q ¤½¥q§iª¾¡A¥uª¾¨Æ¥óÁ`¼Æ¡A¤£ª¾¹êÅç²Õ¡B¹ï·Ó²Õ¦U¬O¦h¤Ö¡A©Ò¥H¤´»Ý´Á¥½¸Ñª¼ ¤½¥q¥²¶·§PÂ_´Á¥½¸Ñª¼®É¶¡ ¤p§Ì¤§«e´¿¼ÒÀÀ§PÂ_¡A¤j¬ùÁ`¨Æ¥ó¼Æ¦b180¥H¤W¡A¤~¦³¸Ñª¼¥i¯à(¥HpÈ¡BHR¤Îpower±À¦ô¡^ °£«D«á¨Ó¨C¤ëªº¨Æ¥óÁ`¼Æ¶V¨Ó¶V¤Ö¡]³o©Î³\¥NªíµÛ¹êÅç²Õ¥i¯àªí²{¥X¦â¡A©M¹ï·Ó²Õ©Ô¶}®t¶Z ©ÒP¡^ ¥H¤W¤DÓ¤H±ÀÂ_¡A¶È¨Ñ°Ñ¦Ò¡AÁÂÁ¡I |
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2017/1/19 ¤U¤È 01:39:29²Ä 3064 ½g¦^À³
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¤Ñ©R¤j ³oÓ»DÃD´NÃø˧Ú, 2015¦~10¤ë ¬OOS ´Á¤¤¤ÀªR,OS Æ[¹î¤¦~ ¤U¤@¦¸OS¤½§i®É¶¡¥i°Ñ¦Ò¥H¤U¸ê°T Secondary Outcome Measures: clinicaltrials.gov/show/NCT01516307 |
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2017/1/18 ¤W¤È 11:48:45²Ä 3063 ½g¦^À³
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¬ü°ê³Ì¦nªºÀù¯gÂå°| ¬ù50®a Àù¯g¯f±w³£·|¶°¤¤¦b³Ì¦nªºÀù¯gÂå°|, ¦b¬ü°ê½æÀù¯gÃÄ«~¦æ¾P¤H¼Æ¤£¥²¤Ó¦h ¤@Ó150¤H¨ì200¤H¥ª¥kªº¤p«¬¹Î¶¤´N¨¬°÷,¤Ï¤§ ½æ¤ß¦åºÞ ¿}§¿¯f ºë¯«¯e¯fÃĪ««h»Ýn8000¤Hªº¤j«¬¹Î¶¤, ¯E¹©¥un¶R¤U¤@¤ä¤p«¬¦æ¾P¤½¥q´N¨¬°÷¤F www.ranker.com/list/u-s-news-best-hospitals-cancer/ceorick |
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2017/1/17 ¤U¤È 04:10:01²Ä 3062 ½g¦^À³
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ÁÂÁ¤ѩR¤j¸ê°T¤À¨É 1 ¦b¨S¦³Áp¦X¥ÎÃĪº±¡ªp¤U 2016 ASCO P13 ¦³§ÜÅé ¨S§ÜÅé²V¦XpºâMOS±µªñ50Ó¤ë ,¦w¥þ¦³®Ä, ¬O¬Û·í´I¦³Ävª§¤O 2 °²³]¦p¤Ñ©R¤j±À¦ôÓ¤H²q´ú P13 MOS ¬ù¦b2017 ¦~ 2¤ë¨ì4¤ë¶¡¼Æ¾Ú¦¨±E ³oӮɶ¡ÂI¤]»P¤p©_¤jªº±À¦ô«Ü±µªñ 3 ASCO P17 MOS¬ù¸¨¦b2018¦~7¤ë¥ª¥k¼Æ¾Ú¦¨±E ,P17·|¤£·|¬O¥þ²y¤T´ÁªºÄw½X, ¹F¨ì¹w©w¼Æ¾Ú,¥þ²y¤T´Á¨ü¸Õ¤]¥´§¹9°w ¤]´N¬O¤G¤ëªk»¡·|·|«á´£°Ýªº¦^µª:°µ¨ì¤@¥b´N®Ö·ÇÃÄÃÒ¥Ó½Ð, ¤]²Å¦X³¯°|¤h´£¨ìªº¦h¦¬¨Ç¯f±w¦ý¹êÅ礣·|ªá«Ü¤[ªº½×z 4 FDA®ÖãBTD¥u¬O¨ä¤¤¿ï¶µ¤§¤@, ¥H±Æ¦C²Õ¦X§Î¦¨ªº¥i¯à¿ï¶µ¨Ó¬Ý¾A¦X822µo®iªº¤è¦V¤]¤£¤Ö,¤j®aÀ³¥H§ó¼e¼sªºµø³¥¨Ó ¬Ý¬ü°êFDA ªº¨M©w ,¬Û«H¬ü°êFDA·|¥H¯f¤Hªº§Q¯q¬°³Ì°ª¦Ò¶qÅý³oÁû³Ð·s«¬,°ª¦w¥þ©Êªº·sÃĦ³¦nªºµo®iªº¤è¦V ±Æ¦C²Õ¦X: A¦¬®×´Á§O:¥H¥|´Á©Î§ó¦´Á¬°¹ï¶H B¦¬®×¤H¼Æ:¥H¤j¤T´Á600-800¤H ¤¤¤T´Á300-500¤H ©Î¤p¤T´Á200¤H¥H¤U CÆ[¹î¶µ¥Ø: OS PFS §ÜÅé DÃÄÃÒ: ª½±µ®ÖãÃÄÃҩήÖ㳡¥÷¨ÅÀù¨È«¬ÃÄÃÒ E³~®|: ¬ð¯}©ÊªvÀøBREAKTHROUGH THERAPY ¥[³t®Öã¾÷¨îACCELERATED APPROVAL ©Î¬O¨ä¥L³~®| ¥H¤W¤À¨É ¦³¨Ç¥i¯à¬O°¾¨£ ¶È¨Ñ°Ñ¦Ò |
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·|û¡GRudy10141433 µoªí®É¶¡:2017/1/17 ¤W¤È 11:19:09²Ä 3061 ½g¦^À³
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¤£·|§âÀù¯g¤T´Á©Ô¶i¨Ó°Õ¡A³oӮɶ¡©Ô¤Óªø¤F¡A¤£¦Eºâ¡C »°®É¶¡¡B»°®É¶¡¡B»°®É¶¡¡A·sÃĬãµo¬O¤@ÓÄvÁÉ¡A«e¦³¼Ä¤H«á¦³°l§L°Ú¡C ˬO¤T³±©Ê±wªÌ¥t¥~°µ³oÓ¤ñ¸û¥i¯à¡Aµ²ªG¥X¨Ó¤ñ¸û§Ö¡A¥ý«÷³¡¤ÀÃÄÃÒ·m¥«³õ¡C |
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2017/1/17 ¤W¤È 11:16:34²Ä 3060 ½g¦^À³
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¤Ñ©R¤j 1 ¦pªG¬Oì¥Äì¨ý ¤£¦©°£®û¼í»~§P»P¥h°£¤T³±©Ê¨ÅÀù ªº±¡ªp¤U ASCO ³o±iP13 (224¤H 124¤H) MOS ? 2 ¦pªG¬Oì¥Äì¨ý ¤£¦©°£®û¼í»~§P»P¥h°£¤T³±©Ê¨ÅÀù ªº±¡ªp¤U ASCO ³o±iP17 (112¤H 112¤H 124¤H) MOS ? ¿ï§ÜÅé®Ä»ù ,¦©°£®û¼í»~§P,¥h°£¬YÃþ«¬¨ÅÀù, »P¥þ³¡¥´§¹9°w¥Øªº¬OnÅý¥þ²y¤T´ÁÁ{§É¸ÕÅ禨¥\ªº¾÷·|¹F¨ì·¥¤j¤Æ |
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·|û¡GVela10140988 µoªí®É¶¡:2017/1/17 ¤W¤È 08:54:39²Ä 3059 ½g¦^À³
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Another one...need to pay to read too OBI Pharma, Inc. 4174 Pharmaceuticals Healthcare Deals and Alliances Profile www.bioportfolio.com/news/article/2917831/OBI-Pharma-Inc-4174-Pharmaceuticals-Healthcare-Deals-and-Alliances-Profile-Prices-from.html |
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·|û¡GVela10140988 µoªí®É¶¡:2017/1/17 ¤W¤È 08:37:48²Ä 3058 ½g¦^À³
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OBI Pharma, Inc. (4174) - Financial and Strategic SWOT Analysis Review www.spi-reports.com/productpdf.php?params=485392 Published the end of last year. Need to order to view |
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·|û¡G²q·Q10136148 µoªí®É¶¡:2017/1/17 ¤W¤È 08:24:24²Ä 3057 ½g¦^À³
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http://www.immunomedics.com/pdfs/news/2016/pr06032016.pdf Sacituzumab govitecan continues to provide a promising median survival benefit in 60 assessable patients with mTNBC who had received a median of 5 (range, 2 ¡V 12) prior lines oftherapy. As of May 2016, the objective response rate (ORR) for this group of patients was 33% (confirmed ORR was 28%), which nearly doubled what has been reported with standard-of-care in this late-stage setting, and the median duration of response was almost 11 months. Median progression-free survival was 5.6 months, which is almost twice as long as conventional therapy,based on historical data, and median overall survival was 14.3 months. The major toxicity was neutropenia, which was manageable, and did not result in cessation of therapy. |
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2017/1/16 ¤U¤È 11:53:29²Ä 3056 ½g¦^À³
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¤Ñ©R¤j 1§Ú¬O°Ý ASCO P13 »P P17 ³o¨â±i¤¤¦ì¼ÆÁ`¦s¬¡´ÁMOS ¬ù¬Û®t´XÓ¤ë ¤]¥i¥H³o¼Ë°Ý ASCO P13 ¹êÅç²Õ224¤H »P¹ï·Ó²Õ124¤H ¤¤¦ì¼ÆÁ`¦s¬¡´ÁMOS±À¦ô¬ù´XÓ¤ë? ASCO P17 §ÜÅé®Ä»ù>=1:160 ²Õ112¤H ¨ä¥L¨â²Õ¤¤¦ì¼ÆÁ`¦s¬¡´ÁMOS±À¦ô¬ù´XÓ¤ë? 2 IgG§ÜÅé®Ä»ù ≥1:40 171 76% ( 4 year survival rate 77.2%) IgG§ÜÅé®Ä»ù ≥1:80 148 66% ( 4 year survival rate 74.8%) ¤W±³o¨â±i©M IgG§ÜÅé®Ä»ù ≥1:160 112 50% ( 4 year survival rate 78.1%) ¬Û¤ñ¸û ¤¤¦ì¼ÆÁ`¦s¬¡´Á MOS ¬O§_«Ü±µªñ? ( ·|°Ý³o¤@ÃD¬O¦]¬° 4 year survival rate 77.2% 74.8% 78.1% ¨ä¹ê«Ü±µªñ) |
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2017/1/16 ¤U¤È 10:31:16²Ä 3055 ½g¦^À³
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IgG§ÜÅé®Ä»ù¤£¦P°ìȤ]¥i¥H¦³¤£¦P¾Ô²¤¦Ò¶q A IgG§ÜÅé®Ä»ù ≥1:160 ªº¾Ô°«¤O ¦p¦P¦Ì°ê ¥§¦Ì¯÷¯Å®Ö°Ê¤O¯èªÅ¥ÀÄ¥ : ( ¥Ø«eÁÙ¬O¥´¹M¤Ñ¤UµL¼Ä¤â Åý¼Ä¤è»D·³àÁx) ¥§¦Ì¯÷¸¹¡]CVN-68¡^ ¼wÃh¯S¡PD¡P¦ã´Ë»¨¸¹¡]CVN-69¡^ ¥dº¸¡P¤å´Ë¸¹¡]CVN-70¡^ ¦è¶ø¦h¡Pù´µºÖ¸¹¡]CVN-71¡^ ¨È§B©Ô¨u¡PªLªÖ¸¹¡]CVN-72¡^ ³ìªv¡PµØ²±¹y¸¹¡]CVN-73¡^ ¬ù¿«¡PC¡P¥v©Z¥§´µ¸¹¡]CVN-74¡^ «¢¨½¡PS¡P§ù¾|ªù¡]CVN-75¡^ ¶©¯Ç¡P¹p®Ú¸¹¡]CVN-76¡^ ³ìªv¡PH¡PW¡P¥¬§Æ¸¹¡]CVN-77¡^ zh.wikipedia.org/wiki/%E5%B0%BC%E7%B1%B3%E8%8C%B2%E7%B4%9A%E6%A0%B8%E5%8B%95%E5%8A%9B%E8%88%AA%E7%A9%BA%E6%AF%8D%E8%89%A6 B IgG§ÜÅé®Ä»ù ≥1:320 ¾Ô°«¤O¦p¦P¦Ì°ê ºÖ¯S¯Å®Ö°Ê¤O¯èªÅ¥ÀÄ¥ 2017¤U¤ô (¦P¯ÅÄ¥ ¥Ì°i}¸¹«Ø³y¤¤ ¥ø·~¸¹³W¹º¤¤ ) zh.wikipedia.org/wiki/%E7%A6%8F%E7%89%B9%E7%B4%9A%E6%A0%B8%E5%8B%95%E5%8A%9B%E8%88%AA%E7%A 9%BA%E6%AF%8D%E8%89%A6 IgG§ÜÅé®Ä»ù ≥1:320 84 38% ( 4 year survival rate 85.9%) IgG§ÜÅé®Ä»ù ≥1:640 50 22% ( 4 year survival rate 91.8%) ³o¨âºØ®Ä»ù ¤¤¦ì¼ÆÁ`¦s¬¡´Á MOS ¹w¦ô·|¬Û·íªø,¥i¥H¯dµÛ¤£¿z¿ï,µ¥¥¼¨Ó¥X²{¼Ä¤â®É¦A¿z¿ïIgG§ÜÅé®Ä»ù ≥1:320¥H¤W ¤Ñ©R¤j 1 §A±À¦ô ASCO P13 »P P17 ³o¨â±i¤¤¦ì¼ÆÁ`¦s¬¡´ÁMOS ¬ù¬Û®t´XÓ¤ë ( ¤£¥²¦Ò¼{ 60Ó¤ë¨î ) 2 IgG§ÜÅé®Ä»ù ≥1:40 171 76% ( 4 year survival rate 77.2%) IgG§ÜÅé®Ä»ù ≥1:80 148 66% ( 4 year survival rate 74.8%) ³o¨â±i©M IgG§ÜÅé®Ä»ù ≥1:160( 4 year survival rate 78.1%) ¬Û¤ñ¸û ¤¤¦ì¼ÆÁ`¦s¬¡´Á MOS ¬O§_«Ü±µªñ ·Å¬Gª¾·s: 2016 07 25 ASCO post ¿ï¥X¤TÁûÃÄ OBI822¦W¦C¨ä¤¤ Quick Takes on Promising New Approaches to Treating Breast Cancer www.ascopost.com/issues/july-25-2016/quick-takes-on-promising-new-approaches-to-treating-breast-cancer/ Promising ¦³§Æ±æªº¡A¦³«e³~ªº¡A¤j¦³¥i¬°ªº Approach ¤èªk , ±µªñ ¡A§Y±N¹F¨ì |
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·|û¡Gbellad10142239 µoªí®É¶¡:2017/1/16 ¤W¤È 09:49:57²Ä 3054 ½g¦^À³
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¬YÂå¥Í4417 www.appledaily.com.tw/appledaily/article/headline/20140105/35557949/ blog.udn.com/leelih2002/9768482 |
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·|û¡GCliff10135274 µoªí®É¶¡:2017/1/16 ¤W¤È 06:35:57²Ä 3053 ½g¦^À³
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105¦~12¤ë27¤éû¤u»{ªÑÅv¾ÌÃÒ(½Z¥»)¡Gpage15/114 ¡u¡K¡K¥xÆW¯E¹©¤w©ó105¦~10¤ë¦V¬ü°ê¹«~ÃĪ«ºÞ²z¸p¡]FDA¡^¥Ó½Ð¥l¶}²Ä¤G´ÁÁ{§É¸ÕÅ秹¦¨·|ij¡]End of Phase 2 meeting¡^¡F¥þ²yÁ{§É¤T´Á¸ÕÅç±N®Ú¾Ú·|ijµ²ªG³W¹º»P°õ¦æ¡C¡K¡K¡v ²×©ó§ä¨ì¤@¶µ¨Ó¦Û©x¤è¥¿¦¡ªº°T®§¡A·PÁÂWendy¤j´£¿ô¡C |
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·|û¡G²q·Q10136148 µoªí®É¶¡:2017/1/15 ¤U¤È 10:39:46²Ä 3052 ½g¦^À³
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§ó¥¿¡G ¬OGH-DT/C34 ¤£¬O GH-DT/CD34 |
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·|û¡G²q·Q10136148 µoªí®É¶¡:2017/1/15 ¤U¤È 10:34:39²Ä 3051 ½g¦^À³
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822 833 GH-DT/CD34 ¥H¤Î SSEA4-DT/C34 ªº¤ñ¸û¡A ½Ð°Ñ http://www.pnas.org/content/110/7/2517.full.pdf |
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2017/1/15 ¤U¤È 08:32:13²Ä 3050 ½g¦^À³
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¯E¹©©xºôµo§G: ³Ìµh¤ÁªºÁn©ú¡A³Ì¸Û¼°ªº´Á¬ß |
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·|û¡G²q·Q10136148 µoªí®É¶¡:2016/12/31 ¤U¤È 07:07:38²Ä 2981 ½g¦^À³
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¾½µßÅé§e²{§ÜÅé®w¤ñ°_¥H¿Ä¦X½F§Þ³N¥Í²£³æ®è§ÜÅé¨ã¦³¤U¦CÀuÂI: (1)¬Ù¥h¤j¶qªº²Ó M°ö¾i; (2)´î¤Ö©Î§K°£°Êª«ªº§K¬Ìª`®g; (3)µL»Ý¶i¦æ¶O®É¤S¶O¤Oªº¤j¶q²ÓM¿z¿ï¨B ÆJ; (4)§ó¾A¥Î©ó¤£¨ã§K¬Ì©Êªº§Üì©Î¬r©Ê§Üì; (5)¨ã¦³Ã©wªº¿ò¶Ç¯S©Ê¡A¥iÀ±¸É¿Ä ¦X½F¿ò¶Ç¯S©Ê¤£Ã©wªº¯ÊÂI¡C ºK¦Ûhttp://lifescience.nuk.edu.tw/LS/word_files/papers/Yang%20Wen-Jen/06.pdf |
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2016/12/31 ¤U¤È 01:25:45²Ä 2980 ½g¦^À³
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1¤Ñ©R¤j«Ü¥Î¥\ªº§ä¸ê®Æ¤S¯à´£¨Ñ¿W¯Sªº¤ÀªR»P¤À¨É¡AÁÂÁ·P®¦¡C 2·|±þÀù²ÓMªº¤£¬O¥u¦³IgG§ÜÅé¡A IgM¤]§êºt¥ý¾W³¡¶¤ªº«n¨¤¦â¡A¹êÅç²Õ·|²£¥Í³o¨âºØ§ÜÅ骺Áp¶°¡A¤ñ¨ÒÀ³¸Ó¤£¤î76% |
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·PÁ¤ѩR¤j ¤Ñ©R¤jªº¤åÄm¡A»á¦³¥i°Ñ¤§³B¡A¤p§Ì±NPFS¤ÎOSªº³¡¥÷ºKn¦p¤U¡G In patients with metastatic breast cancer that is positive for human epidermal growth factor receptor 2 (HER2), progression-free survival was significantly improved after first-line therapy with pertuzumab, trastuzumab, and docetaxel, as compared with placebo, trastuzumab, and docetaxel. Investigator-Assessed Progression-free Survival In the investigator-assessed intention-to-treat analysis, events occurred in 284 of 402 patients (70.6%) in the pertuzumab group and 320 of 406 patients (78.8%) in the control group (hazard ratio, 0.68; 95% CI, 0.58 to 0.80; P<0.001) The results of subgroup analyses were consistent . The medians were unchanged from the May 2012 interim analysis (18.7 months in the pertuzumab group and 12.4 months in the control group, an improvement of 6.3 months) Overall Survival Intention-to-Treat Population Deaths were reported in 168 of 402 patients (41.8%) in the pertuzumab group and in 221 of 406 patients (54.4%) in the control group (hazard ratio favoring the pertuzumab group, 0.68; 95% confidence interval [CI], 0.56 to 0.84; P<0.001) The median overall survival was 56.5 months (95% CI, 49.3 to not reached) in the pertuzumab group and 40.8 months (95% CI, 35.8 to 48.3) in the control group, a difference of 15.7 months. The estimated Kaplan¡VMeier overall survival rate was 94.4% (95% CI, 92.1 to 96.7) in the pertuzumab group and 89.0% (95% CI, 85.9 to 92.1) in the control group at 1 year; 80.5% (95% CI, 76.5 to 84.4) and 69.7% (95% CI, 65.0 to 74.3), respectively, at 2 years; 68.2% (95% CI, 63.4 to 72.9) and 54.3% (95% CI, 49.2 to 59.4), respectively, at 3 years; and 57.6% (95% CI, 52.4 to 62.7) and 45.4% (95% CI, 40.2 to 50.6), respectively, at 4 years. |
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¯E¹©ªº¼ç¤O¯E¤Í¤£¬O¥u¬Ý¨ÅÀù¡A³o¦¸¥xÆW¤T´Á¾Ç¨ìªº¸gÅçÀ³¥Î¦b822¨ä¥L¥|ºØÀù¯gªºÁ{§É³]p¤W¦¨¥\ªº¾÷·|·|¤j«Ü¦h¡A¦]¬°³£¬O¤H¤f¼Æ«Ü¤jªº¤jÃÄ(ªÍÀù ¤j¸zÀù¡A¨xÀù¡AGÀù)¡A¥un¦³¨âºØÀù¯g¦b¤G´Á¬Ý¨ì·¥¨Îªº¼Æ¾Ú¡AÀò±o¬ð¯}©ÊªvÀø®Ö㪺¾÷·|¤j¡Aª½¨úÃÄÃÒ¾÷·|¤]¤£¯à±Æ°£¡A833³o§â¼C¤]¬O«Ü¾U§Qªº¡A¦p¦P822¨ä¥L¥|ºØÀù¯g¤@¼Ë¦³«Ü¤j¾÷·|Àò±o¬ü°êFDA¯S§O³qÃö§¹J¡C ¥H¤W¬Ýªk¤À¨É¡A¥i¯à¬O°¾¨£¡A¶È¨Ñ°Ñ¦Ò¡C |
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·|û¡Gwalker10141977 µoªí®É¶¡:2016/12/28 ¤U¤È 02:36:50²Ä 2959 ½g¦^À³
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OBI ¦û sbot À禬 41% ¸U¤@ obi ¯uªºn°µ¤@¤d¤Hµ¥¯Åªº¤T´Á¡Asbot ªÑ»ùÀ³¸Ón¦³©Ò¤Ï¬M |
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¤Ñ©R¤j: 5.2 ¦~À³¸Ó¬O±q´£¥X¤@´Á IND¥Ó½Ð¨ì´£¥XNDA/BLA¥Ó½Ð¤§¶¡ªº®É¶¡ ¤£¬O®³¨ìBTD®Öã«áÁÙn5.2¦~¤~´£¥XNDA/BLA ÃÄÃҥӽР¤@¯ëÃĪ«( ¨S®³¨ìBTD) ±q ´£¥X¤@´ÁÁ{§É¥Ó½Ð¨ì ´£¥X¥Ó½ÐÃÄÃÒ¬ù»Ý¶}µo¬ù7.4¦~ The analysts say the median time between submission of an investigational new drug application (IND) and a new drug application (NDA) or biologics license application (BLA) is 7.4 years for non-breakthrough products, but only 5.2 years for products with the designation. |
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·|û¡G²q·Q10136148 µoªí®É¶¡:2016/12/25 ¤U¤È 07:08:32²Ä 2942 ½g¦^À³
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2016/12/25 ¤U¤È 05:29:45²Ä 2941 ½g¦^À³
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²q·Q¤j ¤Ñ©R¤j ²³¤j¤j ¦Ñ¥v¤j´£¨Ñªº¸ê°T¤¤ IMMU-132 IMMU-132 (Breakthrough Therapy designation from FDA in metastatic triple- negative breast cancer) IMMU-132: Summary Efficacy Page 8 www.immunomedics.com/pdfs/company-presentation.pdf ³oÁûÃÄÀò±o¬ü°êFDA BTD , OBI 822 »P IMMU-132 PK ¤@¤U ¬O§_¦³Ävª§¤O ? |
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2016/12/25 ¤W¤È 10:32:06²Ä 2938 ½g¦^À³
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ÁÂÁÂ¥v¤j«ü¾É ²q·Q¤jªº¸É¥R ¬ãµo¶µ¥Økite (CAR) ¨t¦C: °¾¦V¦å²G¯e¯f ²O¤ÚÀù (TCR) ¨t¦C: ¥Dn¤ñ¥H©TºA¸~½F¬°¬ãµo¾AÀ³¯g §Ú·|´£kite ³oÀɪѲ¼¤£¬On®³¨Ó»POBI ¤ñÁ`¥«È §Ú¥u¬O¦b»¡©úEPS ¬Otªº±¡ªp¤U¬ü°ê§ë¸ê¤H / §ë¸ê¾÷ºc µ¹¤©47.9¬ü¤¸ ¥un¬O§ë¸ê¾÷ºc¨Ï¥Î©w©Ê¤ÀªR,¤£¬O¨Ï¥Î©w¶q¤ÀªR¤~·|¦³³oºØ»ù¦ì, ¤½¥qªº¬ãµo²£«~, Pipeline ªº¼s«×¶i«×»P¼ç¤O, ¬ãµo¹Î¶¤ªº±j®z,²{ª÷¬O§_¨¬°÷¬Oµû¦ôªºÃöÁä ³o¬O§Ú«e«á¨â¦¸´£¨Ñ¤À¨Éªº¥D¶b www.investopedia.com/articles/stocks/11/qualitative-analysis-biotech-companies.asp §Ú´£¨ìOBI822¤£¨ì8¬ü¤¸ ¬O¦b¤ÏÀ³¨â°ê¹ïµû¦ô¥Í§Þ¤½¥qªº«äºû®t²§¤Ó¤j OBI822¨ì2017¦~¦Ü¤Ö6ºØÀù¯g¶i¤J¬ãµo,³£¬O2´Á¥H¤W OBI888 2017¦~¤]n¶i¤J¤@´ÁÁ{§É¸ÕÅç( ¾AÀ³¯g¥Ø«eÁÙ¤£ª¾¹D) , OBI833 ¦³4ºØÀù¯g¥¿¶i¤JÁ{§É¤@´Á¸ÕÅ礤 ¯E¹©ªºPipeline ªº¼s«×¶i«×³¡Â_¦b¶i®i¤¤,¦w¥þ©Ê°ª¤S¬O³Ð·s«¬·sÃÄ ¯E¹©¨ä¹ê¬O«Ü¦³¼ç¤Oªº¤½¥q,¥u¬O¨â°ê¹ïµû¦ô¥Í§Þ¤½¥qªº«äºû®t²§¤Ó¤j¦Ó¤w ¥xÆWnµo®i¥Í§Þ²£·~ À³ºÉ³t°ö¾i¨ã¦³¸ó»â°ì»P°ê»Úµø³¥ªº¥Í§Þµû¦ô¤H¤~ |
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·|û¡G²q·Q10136148 µoªí®É¶¡:2016/12/25 ¤W¤È 10:09:16²Ä 2937 ½g¦^À³
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Ó¤Hı±o CRTªº¤½¥q ³Ì«nªº¬O ¯à§_µo®i²§Åé²¾¤J§Þ³N ¨ä¥L¤½¥qªº¸ê®Æ ¤]½Ð°Ñ¦Ò ¦U¤½¥qªº»ùÈ ´N¥æ¥Ñ¥«³õ¨M©w§a ¶È¨Ñ°Ñ¦Ò ÁÂÁ¤j®a! Immunomedics, Inc. http://www.immunomedics.com/pdfs/news/2016/pr06032016.pdf Morris Plains, NJ, June 3, 2016 --- Immunomedics, Inc., (Nasdaq: IMMU) today announced that the Company was advised late yesterday that its abstract, ¡§Therapy of refractory/relapsed metastatic triple-negative breast cancer (mTNBC) with an anti-£Vrop-2-SN-38 antibody-drug conjugate (ADC), sacituzumab govitecan (IMMU-132): Phase II results,¡¨ planned for oral presentation today and selected by the American Society of Clinical Oncology (ASCO) for its Press Briefing, was cancelled because of a complaint that the Company violated the embargo by reporting results presented by its Chairman at a conference in April. It appears the complaint was made by a third party contacting ASCO. No question was raised on the quality of the results. Immunomedics President and Chief Executive Officer, Cynthia L. Sullivan, remarked: ¡§The presenter, Dr. Bardia, and I are attempting to reverse this with ASCO, because we believe the patient population and results reported in April were different from those in the ASCO abstract submitted last February. Both we and our many investigators involved are disappointed that our excellent therapeutic results, achieving an interim median survival of about 14 months, may not be presented at this meeting. These results are very encouraging for TNBC patients with metastatic disease who failed multiple prior therapies.¡¨ Sacituzumab govitecan continues to provide a promising median survival benefit in 60 assessable patients with mTNBC who had received a median of 5 (range, 2 ¡V 12) prior lines of therapy. As of May 2016, the objective response rate (ORR) for this group of patients was 33% (confirmed ORR was 28%), which nearly doubled what has been reported with standard-of-care in this late-stage setting, and the median duration of response was almost 11 months. Median progression-free survival was 5.6 months, which is almost twice as long as conventional therapy, based on historical data,1-6 and median overall survival was 14.3 months. The major toxicity was neutropenia, which was manageable, and did not result in cessation of therapy. These results were discussed with the U.S. Food and Drug Administration (FDA) during a recent Breakthrough Therapy Designation (BTD) follow-on meeting. Sacituzumab govitecan has previously received BTD from the FDA for the treatment of patients with TNBC who have failed at least two prior therapies after their cancer has metastasized. After receiving guidance from the regulatory authority, the Company plans to pursue accelerated approval for sacituzumab govitecan as a treatment for patients with TNBC in this setting. The application for Accelerated approval will be based on the ongoing Phase 2 trial with efficacy data, expanding the patient population over the next few months. In addition, a confirmatory Phase 3 clinical study based upon the Special Protocol Assessment (SPA) trial design that the FDA agreed in December 2015 is planned to begin patient enrollment by the end of this calendar year. The company plans to publish the Phase 2 study results in a peer-reviewed medical or cancer journal as soon as possible, so that the medical community can have full access to the clinical trial findings. Overcoming Endocrine Resistance in Hormone-Receptor Positive Advanced Breast Cancer-The Emerging Role of CDK4/6 Inhibitors Ciara C O¡¦Sullivan* Published: October 14, 2015 http://clinmedjournals.org/articles/ijccr/international-journal-of-cancer-and-clinical-research-ijccr-2-029.php?jid=ijccr ºKn three oral highly selective cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) are in various stages of clinical development: PD0332991 (palbociclib), LEE011 (ribociclib) and LY2835219 (abemaciclib). Palbociclib (PD0332991) The PALOMA-1 study (NCT00721409) was a multicen |
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·|û¡G¦Ñ¥v10140531 µoªí®É¶¡:2016/12/25 ¤W¤È 08:36:52²Ä 2936 ½g¦^À³
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1 µn®p¤j§ë¸êÆ[©À¬Û·í¥¿½T,Àù¯gÃĪ«¬ãµo¦¨¥\¾÷²v¬Û·í§C,¬ù¬ãµo18 ÁûÃĤ¤¥u¦³¤@Áû·|¦¨¥\,°µ¦n·ÀIºÞ±±¬O«Ü«nªº 2 ¥»ªi¦^¶^¤£¬O¥u¶^¯E¹©, ¬ü°ê NBI Index¤]¬O¦^¶^,¤U±³o¤äEPS -4.6¬ü¤¸ °µ§K¬ÌÀøªkªº¥Í§Þ¤½¥q Kite Pharma ±q86.43 ¶^¨ì41.47 3 ¤j®a¤£nı±o©_©Ç ¬°¤°»òEPS t4.6¬ü¤¸ ªÑ»ùÁÙ¦³ 1320¤¸¥x¹ô, ¬ü°ê§ë¸ê¾÷ºcºÆ¤F¶Ü ? finance.yahoo.com/quote/KITE?ltr=1 ÁÙ¦³§ó¶Qªº ¦³Àò§Qªº Regeneron Pharmaceuticals, Inc. (REGN) 381.78 ¬ü¤¸ finance.yahoo.com/quote/regn?ltr=1 4 ¬ü°ê§ë¸ê¾÷ºc¨S¦³ºÆ,¦]¬°µû¦ô¥Í¤½¥q¬O¨Ï¥Î©w©Ê¤ÀªR,¤£¬O¨Ï¥Î©w¶q¤ÀªR,¥xÆWnµo®i¥Í§Þ²£·~«o¨S¦³¦X®æªº¥Í§Þ²£·~ ¤ÀªR¤Hû,¥u¦³¤ñ¸û¦³¦Wªº¥~¸ê¾÷ºc¤~¦³³oºØµ}¦³ªº¸ó»â°ì¤H¤~(¬Ý¬ãµo²£«~,¶i«×,¼s«×,±M§Q,ºÞ²z¸gÅç ,¦X§@¹Ù¦ñ,°]°È ) www.investopedia.com/articles/stocks/11/qualitative-analysis-biotech-companies.asp ¤]¦³¬Ý³o¤T¼Ë¬°¥unµû¦ô«ÂI there are three main keys to focus on while looking at a bio-pharmaceutical company. 1) Cash 2) Catalysts ( ¶Ê¤Æ¾¯: À³¬O«ü®ø®§±«¤j§Q¦h¤½§i) 3) Pipeline Potential www.wallstreetoasis.com/forums/guide-to-evaluate-a-biotech-company 5 Àù¯g§K¬ÌÀøªk¥H¨ÅÀù¬°¾AÀ³¯g OBI822 ºâ¬O¨«¦b³Ì«e±ªº,ÁÙ¦n¨S³Q«Ê±þ§_«h´N game over, ÁöµMµLªk¤@À»±o¤À, ¦ý¤]¸ÛÄÝÃø¯à¥i¶Q,³oÁû¨ÅÀùÃĥثe´§¥X¤TÂS¦w¥´, ¶¤¤Í¶i¤J¤@¤GÂS,·Ç³Æ±o¤À (¾Ç¨ì¦p¦ó¬D¿ï¥´ªÌ, ¦w±Æ´Î¦¸ ,½Õ¾ã¥´À»µ¦²¤,·Ç³Æ±o¤À) (¾Ç¨ì¦p¦ó¬D¿ï¯à²£¥Í§ÜÅ骺¯f±w,½Õ¾ã¹êÅç³]p,Åý©¹«áªº¤T´Á³]p»P¨ä¥L¾AÀ³¯gªºÁ{§É³]p¦¨¥\ªº¾÷²v·¥¤j¤Æ) ¥H¤W¤À¨É ´£¨Ñ°Ñ¦Ò |
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·|û¡G²q·Q10136148 µoªí®É¶¡:2016/12/23 ¤U¤È 06:57:03²Ä 2929 ½g¦^À³
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·|û¡G¯º¦10143600 µoªí®É¶¡:2016/12/23 ¤U¤È 06:33:17²Ä 2928 ½g¦^À³
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·|û¡GCliff10135274 µoªí®É¶¡:2016/12/23 ¤U¤È 04:29:20²Ä 2927 ½g¦^À³
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EOP2 meeting n½Í¨Ç¬Æ»ò¡H¡]from ¡uMeeting with FDA¡v¡^ FDA 21 CFR 312.47 (b) (1)¡G End of Phase 2 (EOP) Meeting ¡G I.Objectives: ¥Øªº 1.To obtain agreement on pivotal study designs, and safety and efficacy endpoints for Phase 3 studies .´N²Ä¤T´ÁÁ{§É¸ÕÅ窺¼Ï¯Ã¸ÕÅç³]p¡B¦w¥þ©Ê¤ÎÀø®Ä©ÊªºÁ{§É«ü¼Ð¹F¦¨¦@ÃÑ¡C 2.To update on progress of PK studies and discuss additional studies needed.§ó·sÃĪ«°Ê¤O¾Ç¡]PK¡^ªº¸ê®Æ¡A¤Î°Q½×¬O§_»Ýn·s¼W¸ÕÅç¡C 3.To assure that pre-clinical data with regard to duration, route of administration, and formulation are supportive of the dose to be used in clinical trials.±´°QÁ{§É«eªº¼Æ¾Ú¡A±qÃĮīùÄò®É¶¡¡B§ë¤©³~®|»P¾¯«¬µ¥¨¤«×¨Ó½T»{¬O§_¤ä«ùÁ{§É¸ÕÅç©Ò±N±Ä¥Îªº¾¯¶q¡C II.CMC¡G¤Æ¾Ç²Õ¦¨¡B»s³y»PºÞ±± ¡]CMC¬OEOP2 meetingªº«nijÃD¡^ 1.To discuss approach to specifications and test methods. °Q½×ÃĪ«³W®æ»PÀË´ú¤èªk¡C 2.To discuss ¡uto be marketed¡v formulation.°Q½×¡u±Nn¤W¥«¡vªº¾¯«¬¡C 3.To evaluate appropriate protocols.µû¦ô¾A·íªº¡]»sµ{¡^pµe¡H 4.To identify other issues or potential problems (novel regulatory or technical concerns) .½T»{¨ä¥LªºÄ³ÃD©Î¼ç¦bªº°ÝÃD¡]·sªk³W©Î§Þ³N¼h±¬ÛÃö¡^¡C ¥Ñ¤W¥iª¾¡AEOP2 meeting¥²µM·|½Í¨ì²Ä¤T´ÁªºÁ{§É¸ÕÅçpµe¡A³oÓ·|¤~¯à¶}±o¤U¥h¡F¬JµM²o¯A¨ì¤T´Áªº¸ÕÅç³]p¡A´N¥²µMn°Q½×¨ì¤wª¾ªº¤G´Á¸ÕÅ窺µ²ªG¡F¦P®ÉÁÙn±a822ªºCMC¸ê®Æ¥h°Q½×¡F¦Ó¥B822ÄÝ©ó¥þ·s°t¤è¡]À³¸Ó¬ONME¡F¤S¬O¥Íª«»s¾¯biotechnology drug¡^§ó¬O»Ýn¦n¦n¶}³oÓ·|¡C §Æ±æ¦~©³¡]?¡^©Î¤@¤ëªì¡]¡H¡^¯à¶¶§Q¥l¶}³oÓ·|ij¡A¦³¤F³o¤@Ó«nªº¶iµ{¡A«áÄòªº³W¹º¤~·|§ó©ú®Ô¡C |
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·|û¡Gwoody10140867 µoªí®É¶¡:2016/12/23 ¤U¤È 12:43:08²Ä 2926 ½g¦^À³
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2016/12/23 ¤U¤È 12:39:05²Ä 2925 ½g¦^À³
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¤Ñ©R¤j ³oÓ¸ê°T´£¨Ñµ¹§A¦³ªÅ¦ô¦ô¬ü°ê¥«³õ ( ¼Ú·ù+¤é¥» À³·|¤ñ¬ü°ê¥«³õ¤j X 1.1 X 1.2 X 1.3 ³£¥i¥H ) Estimated New Cancer Cases and Deaths by Sex, United States, 2016* onlinelibrary.wiley.com/doi/10.3322/caac.21332/pdf ( page 9 ) °£¤F¨ÅÀù§Z±_Àù¥~ ¯E¹©OBI822 (ªÍÀù ¤j¸zÀù ¨xÀù GÀù³£¬O¤jÃÄ ±N¶i¤J¤G´ÁÁ{§É), 833(¤w¶i¤J¤@´ÁÁ{§ÉªÍÀù ¤j¸zÀù ¨ÅÀù GÀù) ±q¥xÆW¤T´Á¨ÅÀùÁ{§É¾Ç¨ì¿ï¯à²£¥Í§ÜÅ骺¯f±w¤§¸gÅç, ¥i¹w´Á¥¼¨Ó¬ãµo¦¨¥\¾÷·|·|¼W¤j«Ü¦h Ó¤H¬ã§P©¹«áªº¬ãµo®É¶¡±N¤j¤jÁYµu , ¥]¬A¤@ ¤G´ÁÁ{§Éµ²§ô®ÉÀò±o¬ð¯}©ÊªvÀø®Ö㪺¥i¯à©Ê¤£¯à±Æ°£ ÁÞ´¹¤ù°t¦XÀù¯g¯f±w°lÂܧÜÅ骺¥«³õ¤]µLªk¦ôºâ ? OBI888 ÄÝ©ó³Q°Ê§K¬Ì ³£·|²£¥Í§ÜÅé ¤@ ¤G´ÁÁ{§Éµ²§ô®ÉÀò±o¬ð¯}©ÊªvÀø®Ö㪺¥i¯à©Ê¤]¤£¯à±Æ°£(¾A¥Î¯f±w¤ñ822 833 ¤j) ¥H¤W¥i¯à¬OÓ¤H°¾¨£ ťť´N¦n ¶È¨Ñ°Ñ¦Ò |
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·|û¡G¯º¦10143600 µoªí®É¶¡:2016/12/23 ¤U¤È 12:28:58²Ä 2924 ½g¦^À³
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¬JµMÁÙ¨S¶}¡AÁp¦X³ø¼g±o´N¬O¿ùªº¡A¦]¬°¤w¥Ó½ÐFDA¤T´Á¡A´N¥²¶·¥l¶}EOP2¡AY¥l¶}EOP2¡A¤½¥q´N¥²¶·¤½§i¡A¦]¬°³o¬O«¤j¨Æ¥ó¡I Y°ò©ó«OÀI°_¨£¡An¥Ó½ÐBTD³q¹L¡AÅý¼Æ¾Ú§óº}«G¤~§ó¥[ç´¡AY¬O¦p¦¹¡A¨º2017¦~¤U¥b¦~¦A¥l¶}¤]´N¤£µL¥i¯à¤F¡A¬O§a¡H |
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·|û¡G¯º¦10143600 µoªí®É¶¡:2016/12/23 ¤W¤È 07:34:13²Ä 2922 ½g¦^À³
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2016/12/22 ¤U¤È 04:15:37²Ä 2921 ½g¦^À³
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ÁÂÁ¤ѩR¤j´£¨Ñ¥tÃþ«äºû 1 °²³]MOS ³£±µªñ60Ó¤ë ³o¤]¤Ó±j¤F ( ¦]¨üMOS©ó60Ó¤ë ³Ì°ª¥u¯àºâ60Ó¤ë) ( OBI822 ¥u¬O³æÃÄ+ ´£°ª§K¬Ì¤Oªº§C¾¯¶q¤ÆÀøÃÄ) (OBI822 ¥u¬O³æÃÄ ÁÙ¨S¦³Áp¦X¥ÎÃĪº±¡ªp¤U ¤Ñ©R¤jªº±À¦ô) ¥H¤U¬°Ó¤H¬Ýªk¤À¨É ¶È¨Ñ°Ñ¦Ò 2 PERJETA® + Herceptin® (trastuzumab) + docetaxel ¬O¤TÃĨ֥Π»ù®æ©ù¶Q ¬I¥´¤ñOBI822¤£¤è«K OBI822 ¤j³¡¤À¬O grade1 grade2 ªº°Æ§@¥Î ¦w¥þ©Ê°ª www.roche.com.tw/content/dam/roche_taiwan/zh_TW/download/Perjeta.pdf 3 ¨ÅÀù OBI822 ¥xÆW¤T´Á©Ò«Ø¥ßªºÁ{§É¼Æ¾Ú¤ÀªR¬Û·í¬Ã¶Q ¥¼¨Ó¦p¹J¨ì±j¤j¹ï¤â®É¨ÅÀù OBI822¥i´£°ª¿z¿ï¯f±wªº°ìÈ ¨Ò¦p¬D¿ï§ÜÅé®Ä»ù IgG >= 1:160 IgG >= 1:320 IgG >= 1:640 ÀH®É«O«ù¾÷°Ê©Ê «i´±±¹ï¥þ²yÄvª§ ¥Ø«e¬D IgG >= 1:40 §Y¥i 171 / 224 (76 % ¾A¥Î ) ±q MPFS¤ÀªRµo²{ IgG >= 1:40 »P 1:80 1:160 1:320 «Ü±µªñ 11.1 -- 11.2 Ó¤ë 1:640 17.6 Ó ¤ë «Ü°ª «Ü¥tÃþ ±q¥|¦~¦s¬¡²v¤ÀªRµo²{ IgG >= 1:40 77.2% , 1:80 74.8% ,1:160 78.1% ¤T²Õ«Ü±µªñ) ( 1:320 85.9% , 1:640 91.8% ³o¨â²Õ¸û°ª) ¥H¤W¬O¥H2015¦~10¤ëªº¸ê®Æ¤ÀªR,¦]Á`¦s¬¡´ÁÆ[¹îÁÙ¥¼§¹¦¨,¯u¥¿¼Æ¾ÚÁÙ·|¦³©Ò§ó°Ê 4 ¥qªk®×¥óÁö¬O¨ÅÀù OBI822 ªº¤zÂZ¦]¯À ¦ý¥Ñ©óªÑ²¼¤w»â¥ý¤ÏÀ³§QªÅ ¯uªº°_¶D¤]¬O§QªÅ¥XºÉ,³o¦bªÑ²¼¥«³õ¬O¥qªÅ¨£ºD ªº¤ÏÀ³, °²³]¬O°_¶D¥H¥~ªº±¡ªp°»¬d²×µ²,¤£ª¾¤ÏÀ³ªº¤è¦¡¬O§_·|¦³©Ò¤£¦P ? |
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