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FDA批准Opdivo用于晚期黑色素瘤

FDA Approves Opdivo for Advanced Melanoma
来源:FDA 2014-12-29 09:37点击次数:3716发表评论

美国FDA 12月22日加速批准Opdivo (nivolumab)用于治疗无法手术切除或已经出现转移且对其它药物无应答的晚期黑色素瘤患者。


黑色素瘤是美国第5大常见的肿瘤类型。该肿瘤由体内可以形成皮肤色素的黑色素细胞形成。美国国家癌症研究所估计,今年将会有76100 名美国人被诊断为黑色素瘤,9710人将会死于该疾病。


Opdivo通过抑制细胞表面的 PD-1蛋白而起作用,这种蛋白会阻断体内免疫系统对肿瘤细胞的攻击。Opdivo用于先前接受过ipilimumab治疗的黑色素瘤患者,以及携带BRAF V600突变的患者,在接受ipilimumab以及一种BRAF抑制剂治疗之后使用。


“Opdivo是自2011年以来第7个被批准用于治疗黑色素瘤的新物,” FDA药物评价和研究中心血液学和肿瘤产品办公室主任Richard Pazdur,博士说。“基于我们对于肿瘤免疫和分子通路理解的提高,新型的治疗方法也得到了持续的发展并获得批准,这种治疗方法正在改变重症及危及生命的疾病的治疗范式。”


FDA批准的其它黑色素瘤治疗药物包括ipilimumab (2011),聚乙二醇干扰素α-2b (2011),vemurafenib (2011),dabrafenib (2013),trametinib (2013) 以及pembrolizumab (2014)。Opdivo的批准时间比PDUFA预定的2015年3月30日提前了3个多月.


因为临床证据证明这种药物可能提供一种使治疗效果获得实质性改善的治疗方法,FDA授予了Opvido突破性治疗药物、优先审评和孤儿药资格,在提交申请的时候,该药物在治疗重症方面就显示出显著的安全性和疗效改善,同时,该药物也很有希望用于罕见疾病的治疗。


Opvido是通过FDA的加速批准通道获得批准的,该项目允许批准用于治疗严重疾病或威胁生命疾病的药物,且需要基于临床数据显示出该药物对于替代终点有效,从而能够合理预测患者临床获益的可能性。该项目在公司仍处于证实药物疗效的附加临床试验阶段就为患者提供了提前获得有希望的新药的途径。


Opdivo的疗效在120例无法手术切除的或转移性黑色素瘤患者中得到证实。 结果显示接受Opdivo的受试者中,有32%的患者肿瘤缩小(客观应答率)。在肿瘤缩小受试者中有大约1/3患者的这一效果持续时间超过6个月。


评估Opdivo安全性的全部试验中接受Opdivo治疗的受试者总人数为268人,使用化疗的受试者总人数为102人。最常见的药物副作用为皮疹、瘙痒、咳嗽、上呼吸道感染和液体潴留(水肿)。最严重的副作用是严重免疫介导的副作用,累及健康的器官,包括肺、结肠、肝脏、肾脏和分泌荷尔蒙的腺体。


Opdivo由总部位于新泽西的百时美施贵宝公司生产上市。


The U.S. Food and Drug Administration today granted accelerated approval to Opdivo (nivolumab), a new treatment for patients with unresectable (cannot be removed by surgery) or metastatic (advanced) melanoma who no longer respond to other drugs.


Melanoma is the fifth most common type of cancer in the United States. It forms in the body’s melanocyte cells, which develop the skin’s pigment. The National Cancer Institute estimates that 76,100 Americans will be diagnosed with melanoma and 9,710 will die from the disease this year.


Opdivo works by inhibiting the PD-1 protein on cells, which blocks the body’s immune system from attacking melanoma tumors. Opdivo is intended for patients who have been previously treated with ipilimumab and, for melanoma patients whose tumors express a gene mutation called BRAF V600, for use after treatment with ipilimumab and a BRAF inhibitor.


“Opdivo is the seventh new melanoma drug approved by the FDA since 2011,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “The continued development and approval of novel therapies based on our increasing understanding of tumor immunology and molecular pathways are changing the treatment paradigm for serious and life-threatening diseases.”


Other FDA-approved treatments for melanoma include ipilimumab (2011), peginterferon alfa-2b (2011), vemurafenib (2011), dabrafenib (2013), trametinib (2013) and pembrolizumab (2014). Opdivo is being approved more than three months ahead of the prescription drug user fee goal date of March 30, 2015, the date when the agency was scheduled to complete its review of the application.


The FDA granted Opvido breakthrough therapy designation, priority review and orphan product designation because the sponsor demonstrated through preliminary clinical evidence that the drug may offer a substantial improvement over available therapies; the drug had the potential, at the time of the application was submitted, to be a significant improvement in safety or effectiveness in the treatment of a serious condition; and the drug is intended to treat a rare disease, respectively.


Opvido is being approved under the FDA’s accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts additional clinical trials to confirm the drug’s benefit.


Opdivo’s efficacy was demonstrated in 120 clinical trial participants with unresectable or metastatic melanoma. Results showed that 32 percent of participants receiving Opdivo had their tumors shrink (objective response rate). This effect lasted for more than six months in approximately one-third of the participants who experienced tumor shrinkage.  


Opdivo’s safety was evaluated in the overall trial population of 268 participants treated with Opdivo and 102 participants treated with chemotherapy. The most common side effects of the drug were rash, itching, cough, upper respiratory tract infections, and fluid retention (edema). The most serious side effects are severe immune-mediated side effects involving healthy organs, including the lung, colon, liver, kidneys and hormone-producing glands.


Opdivo is marketed by Princeton, New Jersey-based Bristol-Myers Squibb.


Copyright © 2014 FDA News Release


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学科代码:肿瘤学 皮肤病学   关键词:FDA Opdivo 晚期黑色素瘤
来源: FDA
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