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FDA拒绝批准肉瘤药物ridaforolimus

来源:环球医学编译    时间:2012年06月07日    点击数:    5星

6月7日消息 - 环球医学据悉,美国食品和药物管理局(FDA)已发出一封完整的答复信,以需要另外的数据为由,拒绝批准ridaforolimus(Taltorvic,由默克公司在Ariad制药的授权下出品)的申请。

口服哺乳动物雷帕霉素靶蛋白(mTOR)抑制剂是一种研究中的药物,用于≥4个周期化疗反应良好的转移性软组织或骨肉瘤患者的维持性治疗。

据该公司发布的消息,在考虑重新申请之前,该药需要另外进行安全性和有效性试验。

FDA的决定并不令人吃惊,因为2012年3月FDA肿瘤药物咨询委员会成员以13-1的表决结果反对批准该药。该委员会的成员表示,该药的不良反应超过了其带来的全部获益。

据此前报道,临床试验表明,ridaforolimus将疾病的进展延缓了16.1周,而安慰剂为14周。公司计算间略有差异(17.7 vs 14.6周)。

无进展生存期增加了2周,但同时需要停止治疗的严重不良事件(如肾功能衰竭、感染和肺部炎症)的风险增加了7倍(14%和2%)。

尽管如此,该公司将坚持努力获得FDA批准。

“默克仍对ridaforolimus的潜力充满信心,”默克公司临床研究肿瘤学副总裁、医学博士Eric Rubin表示。“我们将继续与FDA密切合作,从而为这种研究中的疗法确定潜在的路径。”(环球医学)

原文:

FDA Rejects Sarcoma Drug

The US Food and Drug Administration (FDA) has issued a complete response letter rejecting a bid for approval of ridaforolimus (Taltorvic, made by Merck & Co Inc under license from Ariad Pharmaceuticals Inc), citing the need for additional data.

The oral mammalian target of rapamycin (mTOR) inhibitor is under investigation as maintenance therapy for patients with metastatic soft tissue or bone sarcoma who respond favorably to 4 or more cycles of chemotherapy.

According to a company news release, additional safety and efficacy trials are required before a new drug application will be considered.

The FDA's decision is unsurprising, coming on the heels of 13-1 vote against the drug's approval among members of the agency's Oncologic Drugs Advisory Committee in March 2012. The committee members said that any potential benefit of the drug was outweighed by its adverse effects.

As previously reported, clinical trials demonstrated that ridaforolimus delayed disease progression for 16.1 weeks compared with 14 weeks in patients given placebo. Company calculations were slightly different (17.7 vs 14.6 weeks).

The 2-week improvement in progression-free survival was accompanied by a 7-fold increase in risk for severe adverse events requiring discontinuation of therapy, such as kidney failure, infection, and lung inflammation (14% vs 2%).

Still, the company will persist in its attempt to gain FDA approval.

"Merck remains confident in the potential of ridaforolimus," stated Eric Rubin, MD, vice president of clinical research oncology at Merck, in the news release. "We will continue to work closely with the FDA to define potential paths forward for this investigational therapy."
 

相关链接:http://www.medscape.com/viewarticle/765172

 

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