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New injectable version of Roche breast cancer drug approved by EMA Å·ÖÞÒ½Ò©¹ÜÀí¾ÖÅú×¼ÂÞÊÏÆìϵÄÈéÏÙ°©ÐÂÐÍ×¢ÉäÒ©Îï ÔÎÄÁ´½Ó http://medcitynews.com/2013/06/n ... -ema/#ixzz2XgrvC4hu ZURICH (Reuters) - Swiss drugmaker Roche said on Friday that European regulators had given a green light to a new formulation of its breast cancer drug Herceptin, which it hopes will help extend the medicine's shelf life. ·͸ËÕÀèÊÀµç-ÈðÊ¿ÖÆÒ©ÉÌÂÞÊÏÓÚÖÜÎåÐû³ÆÅ·ÖÞÒ½Ò©¹ÜÀíÕßÒѾΪËûÃÇÑз¢µÄÈéÏÙ°©Ò©ÎïºÕÈû͡мÁÐÍ¿ªÁËÂ̵ƣ¬ÂÞÊÏÏ£ÍûÕâÖÖмÁÐÍ¿ÉÒÔÑÓ³¤ºÕÈûÍ¡µÄרÀûȨÆÚÏÞ¡£ The European Medicines Agency (EMA) said that its experts had recommended approval of a new injectable version of Herceptin, which cuts down treatment time to just two to five minutes. It currently takes between 30 to 90 minutes to administer the drug intravenously. Å·ÖÞÒ½Ò©¹ÜÀí¾Ö³ÆÆäר¼Ò½¨ÒéÅú×¼ºÕÈûÍ¡µÄÐÂ×¢Éä¼ÁÐÍÒ©Î¸ÃмÁÐͿɽ«ÖÎÁÆÊ±¼äËõ¶ÌÖÁ2~5·ÖÖÓ¡£¶øÄ¿Ç°ºÕÈûÍ¡¾¾²Âö×¢Éä¸øÒ©µÄÖÎÁÆÊ±¼äÐè30~90·ÖÖÓ¡£ Herceptin, known generically as trastuzumab, is used as a treatment for around a quarter of breast cancer patients who have tumors that generate a protein called HER2, which tends to make their disease more aggressive. ºÕÈûÍ¡£¬Í¨³£Ò²½ÐÇúÍ×Öéµ¥¿¹£¬ÓÃÓÚÖÎÁÆÔ¼ËÄ·ÖÖ®Ò»µÄÒòHER2µ°°×Ö°©µÄÈéÏÙ°©»¼Õߣ¬¸Ãµ°°×¿Éʹ»¼ÕߵIJ¡Çé¸ü¼Ó¶ñ»¯¡£ Recommendations for marketing approval by the agency's Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months. Å·ÖÞÒ©Æ·¾ÖÈËÓÃҩƷίԱ»á(CHMP)¶Ô¸ÃÒ©ÉÏÊÐÐí¿ÉµÄÍÆ¼öͨ³£»áÔÚÁ½¸öÔÂÄڵõ½Å·ÃËίԱ»áµÄÅú×¼¡£ June 28, 2013 11:49 am by Staff »¶Ó´ó¼Ò¾À´íºÍÖ¸Õý~ [ Last edited by zhtear99 on 2013-6-30 at 18:29 ] |
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