Bristol-Myers to submit BLA for nivolumab in melanoma
Bristol-Myers Squibb Co. (NYSE:BMY) said it plans to submit a BLA to FDA this quarter for Opdivo nivolumab to treat previously treated advanced melanoma. The pharma has already started a rolling BLA for nivolumab as third-line treatment of squamous non-small cell lung cancer (NSCLC). BMS expects to complete the application by year end. BMS has worldwide rights to nivolumab -- a human IgG4 mAb against PD-1 receptor ( PDCD1; PD-1; CD279) -- from Ono Pharmaceutical Co. Ltd. (Tokyo:4528), excluding Japan, Korea and Taiwan, where Ono retains rights.
Last Friday, Japan's Ministry of Health, Labor and Welfare (MHLW) approved Opdivo to treat unresectable melanoma. Ono said it plans to launch the drug "rapidly" after National Health Insurance (NHI) listing, which is expected within 60 days (see BioCentury Extra, July 7). ...