Japan approves drugs for cancer, HCV, TB

Japan's Ministry of Health, Labor and Welfare (MHLW) approved several new drugs on Friday, including Opdivo nivolumab from Ono Pharmaceutical Co. Ltd. (Tokyo:4528) to treat unresectable melanoma. The approval requires Ono to conduct a postmarketing survey and collect safety and efficacy data from an undisclosed number of patients. Ono said this is the first approval worldwide for a programmed cell death 1 ( PDCD1; PD-1; CD279) inhibitor.

Bristol-Myers Squibb Co. (NYSE:BMY) has worldwide rights to nivolumab -- a human IgG4 mAb against PD-1 -- from Ono, excluding Japan, Korea and Taiwan, where Ono retains rights. In the U.S., BMS is initially pursuing approval for non-small cell lung cancer (NSCLC). The pharma has started a rolling BLA for nivolumab as third-line treatment of squamous NSCLC. ...