BioCentury
ARTICLE | Company News

CHMP backs Opdivo and Hetlioz, spurns Lympreva

April 25, 2015 1:14 AM UTC

EMA's CHMP issued several recommendations on Friday, backing marketing authorization of candidates from Bristol-Myers Squibb Co. (NYSE:BMY) and Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) while declining to recommend one from Biovest International Inc. (Minneapolis, Minn.).

CHMP recommended approval of BMS's Opdivo nivolumab as monotherapy to treat advanced melanoma. The committee has not yet issued a recommendation on Opdivo to treat non-small cell lung cancer (NSCLC); Opdivo is under EMA review for both indications. FDA approved the drug last month to treat metastatic squamous NSCLC, and in December 2014 to treat advanced melanoma. BMS has worldwide rights to the human IgG4 mAb against PD-1 from Ono Pharmaceutical Co. Ltd. (Tokyo:4528), excluding Japan, Korea and Taiwan, where Ono and BMS are partnered. ...