FDA Accepts BMS’ BLA for Opdivo for Lung CancerBy
Bristol-Myers Squibb reports that the US Food and Drug Administration (FDA) has accepted for filing and review its biologics licensing application (BLA) for Opdivo (nivolumab) for the treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) after prior therapy. The FDA also granted priority review for this application. The Prescription Drug User Fee Act (PDUFA) goal date for a decision is June 22, 2015.
In 2014, Bristol-Myers Squibb received approval for Opdivo for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor.
In 2011, through a collaboration agreement with Ono Pharmaceutical, Bristol-Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Bristol-Myers Squibb and Ono Pharmaceutical further expanded the companies' strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies, as single agents and combination regiments, in Japan, South Korea and Taiwan.
Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 50 trials as a monotherapy or in combination with other therapies.
Source: Bristol-Myers Squibb