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2015Äê2ÔÂ3ÈÕ£¬ÃÀ¹úʳƷºÍÒ©Îï¹ÜÀí¾Ö£¨FDA£©¼ÓËÙÅú×¼ÁËPalbociclib£¨ÉÌÆ·ÃûIbrance£¬ÃÀ¹ú»ÔÈð¹«Ë¾Éú²ú£©ÁªºÏÀ´ÇúßòÓÃÓÚÖÎÁÆERÑôÐÔ¡¢HER2ÒõÐÔ¡¢¾ø¾ºóµÄÍíÆÚÈéÏÙ°©µÄÊ×Ñ¡ÄÚ·ÖÃÚÖÎÁÆ¡£ PalbociclibÊÇÒ»ÖÖCDK4/6ÒÖÖÆ¼Á¡£ÕâÏîÅú×¼ÊÇ»ùÓÚÒ»ÏîËæ»úÁÙ´²ÊÔÑéÑо¿µÄÓÐЧ½á¹û£¬¸ÃÑо¿»¼ÕßÈë×é±ê×¼ÊÇ£º¾ø¾ºóµÄ¡¢ERÑôÐÔ¡¢HER2ÒõÐÔ¡¢¾Ö²¿ÍíÆÚ»ò×ªÒÆµÄ¡¢Õë¶ÔÍíÆÚ²¡ÔîÏÈǰûÓнÓÊܹýϵͳÖÎÁƵÄÈéÏÙ°©»¼Õß¡£¸ÃÑо¿ÄÉÈë165Ãû»¼Õߣ¬Ëæ»ú·ÖΪÁ½×飺½ÓÊÜPalbociclib+À´Çúßò×é»òµ¥¶ÀÀ´Çúßò×é¡£ ½á¹ûÏÔʾƽ¾ùÎÞ½øÕ¹Éú´æÆÚ£¨PFS£©ÔÚPalbociclib¼ÓÀ´Çúßò×éΪ20.2¸öÔ£¬ÔÚµ¥¶ÀʹÓÃÀ´Çúßò×éΪ10.2¸öÔ¡£ ×î³£¼ûµÄ²»Á¼·´Ó¦£¨·¢ÉúÂÊ¡Ý10%£©ÊÇ£ºÖÐÐÔÁ£Ï¸°û¼õÉÙ¡¢°×ϸ°û¼õÉÙ¡¢·¦Á¦¡¢Æ¶Ñª¡¢ÉϺôÎüµÀ¸ÐȾ¡¢¶ñÐÄ¡¢¿ÚÇ»Ñס¢ÍÑ·¢¡¢¸¹Ðº¡¢ÑªÐ¡°å¼õÉÙÖ¢¡¢Ê³ÓûϽµ¡¢Å»Í¡¢ÎÞÁ¦¡¢ÖÜΧÉñ¾²¡±äºÍ±Ç³öѪ¡£ÔÚPalbociclib¼ÓÀ´Çúßò×é·¢ÉúƵÂÊ×î¸ßµÄÑÏÖØ²»Á¼·´Ó¦ÊÇ£º·Î˨Èû£¨4%£©ºÍ¸¹Ðº£¨2%£©¡£ PalbociclibÍÆ¼öµÄ¼ÁÁ¿ºÍÓ÷¨ÊÇ£ºÃ¿Ìì125ºÁ¿Ë£¬Á¬ÓÃ21Ì죬ÐÝÏ¢7Ì죻ͬʱ¸øÓèÀ´ÇúßòÿÌì2.5ºÁ¿Ë£¬Á¬ÓÃ28Ìì¡£ PalbociclibµÄÏêϸ´¦·½ÐÅÏ¢Ïê¼û£ºhttp://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207103s000lbl.pdf ×¢£º PalbociclibµÄ´´ÐÂÖ®´¦ÔÚÓÚÒԴƼ¤ËØÊÜÌåΪ°Ð±ê£¬×è¶ÏCDK4ºÍCDK6Á½ÖÖø£»ÎªÓÐ×ªÒÆµÄ¾ø¾ºóÈéÏÙ°©»¼ÕßÌṩÁËеÄÖÎÁÆ·½°¸£ºPalbociclib¼ÓÀ´Çúßò¡£ CDK4/6ÊÇϸ°û·ÖÁÑÖÜÆÚµÄÖØÒªµ÷½Úµ°°×£¬ÓÕ·¢Ï¸°û´ÓG1µ½S½×¶ÎµÄת»¯¡£ÒÖÖÆCDK4/6²»½ö¿ÉÒÔʹϸ°û·ÖÁÑÍ£Ö¹£¬¶øÇÒ¿ÉÒÔɱËÀÒÑÓеݩϸ°û¡£ ·Ò룺ÃÀ¹ú Methodist Hospital Ö×Áö¡¢ÑªÒº×¨¼Ò¡¢ÄڿƸ±Ö÷ÈÎ Henry Wang ÃÀ¹ú City of Hope National Medical Center ·ÃÎÊѧÕß Dr. Wang Hailong ÔÎÄ£º On February 3, 2015, the U. S. Food and Drug Administration granted accelerated approval to palbociclib (IBRANCE, Pfizer, Inc.) for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease. Palbociclib is an inhibitor of cyclin-dependent kinase (CDK) 4 and 6. The approval is based on a randomized trial in postmenopausal women with ER-positive, HER2-negative, locally advanced or metastatic breast cancer who had not received previous systemic treatment for advanced disease. The trial enrolled 165 patients randomly allocated to receive either palbociclib plus letrozole or letrozole alone. Median progression-free survival (PFS) was 20.2 months in the palbociclib plus letrozole arm and 10.2 months in the letrozole alone arm. Most common adverse reactions (greater than or equal to 10%) were neutropenia, leukopenia, fatigue, anemia, upper respiratory infection, nausea, stomatitis, alopecia, diarrhea, thrombocytopenia, decreased appetite, vomiting, asthenia, peripheral neuropathy, and epistaxis. The most frequently reported serious adverse reactions in patients receiving palbociclib plus letrozole were pulmonary embolism (3 of 83; 4%) and diarrhea (2 of 83; 2%). The recommended dose and schedule of palbociclib is 125 mg daily for 21 consecutive days followed by 7 days off treatment with letrozole 2.5 mg daily continuously throughout the 28-day cycle. Full prescribing information is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207103s000lbl.pdf |
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