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四个工作日!施贵宝公司肿瘤新药Opdivo获批速度创纪录

  1. FDA
  2. Opdivo
  3. PD-1
  4. 施贵宝
  5. 肺癌

来源:生物谷 2015-03-05 19:07

FDA的工作人员感慨其从事药物审批工作十几年,还没有见过获批如此迅速的药物。

2015年3月5日讯 /生物谷BIOON/--新年刚过,百时施贵宝公司就迎来了一个喜气洋洋的好消息。公司开发的PD-1药物Opdivo获得FDA的扩大适应症批准。此前,FDA已经在去年批准Opdivo用于治疗黑色素瘤(相关阅读:FDA接受施贵宝PD-1抑制剂Opdivo治疗肺癌上市申请,免疫疗法进入主流实体瘤)。

此次FDA同意将Opdivo的适应症扩大到肺癌治疗领域。这一消息无疑是给施贵宝公司封了一个大大的新年红包,自去年Opdivo上市以来,市场反响强烈。一些生物医药产业分析人士预计这一药物的销售峰值将可能达到50亿美元之多,而此次Opdivo被批准用于非细小型细胞肺癌的治疗,将把这种药物的销售额再提高10亿美元之多!

所谓PD-1药物,既最近几年兴起的,针对肿瘤细胞PD-1通路为靶点设计的药物。顾名思义,这种药物能够特异性的阻断肿瘤细胞的PD-1通路,而后者则是肿瘤细胞逃避检验点检测的重要手段之一。根据施贵宝提供的临床三期研究显示,相比于传统的阿霉素化疗疗法,Opdivo能够显著提高患者的总体生存率。

此次,FDA批准Opdivo用于治疗非细小型细胞肺癌也创造了FDA的审批记录,FDA做出这一决定的时间比其预定时间早了三个月之多。无怪乎一位FDA的工作人员感慨其从事药物审批工作十几年,还没有见过获批如此迅速的药物。

大家可千万不要小看这三个月。Opdivo的提前获批不仅帮助施贵宝公司在PD-1药物研发领域占得先机,还帮助其领先它的主要对手——默沙东。作为PD-1药物领域的另一个重量级选手,默沙东公司的Keytruda同样于去年获得批准用于治疗皮肤癌(相关阅读:PD-1市场硝烟再起,默沙东将向FDA提交Keytruda肺癌适应症审批申请)。但是Keytruda用于治疗肺癌的相关审批工作预计将到2015年年底才能完全完成。这就给施贵宝公司长达一年的时间,开拓市场。

而目前施贵宝公司正在努力的方向和绝大多数肿瘤药物研发者一样,那就是努力拓展Opdivo的适应症范围。一般而言,肿瘤疗法的开发会重点集中在黑色素瘤、肺癌等领域。这主要是因为黑色素瘤这种皮肤癌的进程容易表现,因而更容易进行临床研究,而肺癌是世界各国重要的肿瘤类型,代表着巨大的市场份额。然而,今年来随着生物医药产业的发展,越来越的生物医药公司开始进入这两种肿瘤市场,想要仅凭这两种肿瘤适应症来包打天下的时代已经一去不复返。

Opdivo的上市标志着PD-1药物的问世,让我们期待这种药物在未来能够带给我们什么样的惊喜。(生物谷Bioon.com)

详细英文报道:

Bristol-Myers Squibb ($BMY) picked up FDA approval to use its new oncology treatment in lung cancer, significantly boosting the value of a therapy already expected to bring in billions each year.

The FDA's latest approval of Opdivo, already cleared for melanoma, comes just days after the agency accepted Bristol-Myers' application and more than three months ahead of schedule. Bristol-Myers' treatment is designed to galvanize an immune system attack on tumors by blocking a pathway called PD-1, which, left unchecked, allows cancer cells to pass undetected by the body's natural defenses.

The agency's nod OKs Opdivo to treat squamous non-small cell lung cancer(NSCLC) that has advanced despite chemotherapy. Squamous patients account for about 30% of the NSCLC population, and Bristol-Myers is at work on a Phase III trial in the larger non-squamous group in hopes of further expanding Opdivo's label. Analysts have speculated Opdivo will bring in peak sales of around $5 billion a year, and Leerink's Seamus Fernandez believes its promise in lung cancer will take that figure as high as $7.3 billion by 2020.

With the approval, Bristol-Myers jumps ahead of Merck ($MRK), its closest rival in the PD-1 space. Merck's treatment, Keytruda, was first to market with a skin cancer approval last year, and the company is doggedly working to catch up in NSCLC. In January, Merck revealed that Keytruda was progressing ahead of schedule, in line for FDA application by mid-2015. And thanks to the therapy's "breakthrough" status at the FDA, Merck could pick up a lung cancer approval as soon as year's end, analysts figure.

Opdivo's speedy lung cancer approval is based on Phase II data in which it significantly increased rates of survival among patients with NSCLC. In January, Bristol-Myers divulged that, in a Phase III study pitting Opdivo against the standard cancer-killer docetaxel, the drug demonstrated such superior overall survival compared with the control arm that it hit its primary endpoint ahead of schedule, leading the trial's data monitoring committee recommend the study be terminated early.

The FDA's rolling review for Opdivo was by far the fastest for any treatment in recent memory and again affirms FDA oncology chief Richard Pazdur's penchant for rapidly approving cancer therapies that could improve the standard of care for some of the most dire patients.

"The FDA worked proactively with the company to facilitate the early submission and review of this important clinical trial when results first became available in late December 2014," Pazdur said in a statement. "This approval will provide patients and health care providers knowledge of the survival advantage associated with Opdivo and will help guide patient care and future lung cancer trials."

Opdivo's second trip through the FDA "is the fastest approval I've seen in my 15-year career," Evercore ISI analyst Mark Schoenebaum noted soon after the news hit. And it's an important one. Sketching out some raw sales forecasts for this indication, Schoenebaum concludes that the approval could be worth an additional $1 billion to $1.5 billion in sales. And more work is ahead to expand its dominance in lung cancer.

Behind Bristol-Myers and Merck, Roche ($RHHBY), AstraZeneca ($AZN), and partners Pfizer ($PFE) and Merck KGaA are bringing up checkpoint inhibitors that promise to change the standard of care for many cancers, a new class of therapies expected to bring in about $35 billion a year.

Like its rivals, Bristol-Myers is bankrolling an expansive R&D effort to determine Opdivo's potential in a wealth of cancers, launching combo trials in hopes of further extending the antibody's use.

"Our research program continues through an innovative and robust pipeline that includes more than 20 tumor types and through collaborations with other companies and researchers across the globe," R&D chief Francis Cuss said in a statement.

 

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