Ono公司nivolumab成为世界上**种获得上市批准抗PD-1药物

近年来在癌症免疫疗法中，基于PD－1的药物研究已经趋于白热化。终于在最近来自Ono生物医药公司开发的此类药物nivolumab获得了世界上第一个管理批准，也标志着nivolumab取得了第一个胜利。Nivolumab是Ono生物公司从Medarex公司获得的，Ono生物医药公司拥有其在日本市场的权利。最近来自日本药物管理部门的消息称，nivolumab已经被批准在日本上市用于治疗黑色素瘤。这种药物将以Opdivo的商业名登陆日本市场。Nivolumab并不是最近日本批准的唯一一个尖端药物。施贵宝公司开发的丙肝药物也同时获得日本管理当局的批准。

详细英文报道：

The anti-PD-1 immuno-oncology drug star nivolumab has won the race to the world's first regulatory checkered flag for an approval. Ono Pharmaceutical, which picked up the Japanese rights to the drug in a collaboration deal with Medarex back in 2005, says regulators in the Asian country approved nivolumab for sale as a treatment for unresectable melanoma.

Ono now says that it plans to make the closely-watched drug available to patients for free as it awaits a listing on the national health insurance price list. The company adds that it's planning to follow up with additional applications for other cancer uses, with plans to launch a post-marketing study on the drug's effects among patients prescribed the cancer treatment.

The immune checkpoint inhibitor will be sold in Japan as Opdivo. And it's not the only cutting-edge therapy to get a pioneering OK in Japan. Bristol-Myers today reported that Japanese regulators have approved a combo hep C therapy - packaging  Daklinza and Sunvepra for genotype 1 patients. This is the first of a number of new cocktails being developed for hep C that will exclude interferon and Ribavirin.

Medarex was bought out by Bristol-Myers Squibb ($BMY), leaving it with a cutting-edge therapy designed to disable the cloaking mechanism that cancer cells use to remain hidden from the immune system. Bristol-Myers owns all rights to the drug outside of Japan, Korea and Taiwan. Nivolumab is one of the leading IO drugs in development, racing against Merck's ($MRK) pembrolizumab (MK-3475), which is engaged in a rolling submission in the U.S. and is under review in Europe.

Merck may be leading the race for the first major market approval, but a number of analysts give Bristol-Myers the edge in developing the drug most likely to gain the biggest market share. This sector is likely to be worth billions of dollars, with combination drugs and monotherapies promising to be a game changer in treating cancer. Roche is also among the leaders in the field, with AstraZeneca coming up from behind with its own ambitious development plans.

Just two weeks ago Bristol-Myers, which has poured hundreds of millions of dollars into its development program, announced that it hit the brakes earlier than planned on a late-stage study of nivolumab after the monitoring committee overseeing interim data concluded that the PD-1 drug provided a clear survival benefit over dacarbazine for BRAF wild-type advanced melanoma when used as a frontline therapy.

"We anticipate that nivolumab will be the sales-leading agent among immunotherapies," noted Decision Resources analyst Khurram Nawaz in a recent piece for PMLive in the UK. "However, it will face direct and intense competition from other anti-PD1/PDL1 agents--notably from pembrolizumab in malignant melanoma and NSCLC--and, to a lesser extent, from MPDL-3280A in NSCL."

"We are delighted to obtain a manufacturing and marketing approval as a drug targeting PD-1, which receives a lot of attention in tumor immunity, for the first time in the world." said Gyo Sagara, president of Ono. "Ono would like to obtain approvals for additional indications on ongoing development for other cancers to bring many patients OPDIVO as soon as possible."