Replies to post #188136 on Biotech Values

[DewDiligence]

BMY’s terse PR on the FDA approval of Opdivo in second-line NSCLC:

http://finance.yahoo.com/news/bristol-myers-squibb-announces-u-192100453.html

Sounds like BMY wasn’t fully prepared for such fast FDA action.

[DewDiligence]

BMY—CheckMate-057 phase-3 Opdivo trial in second-line non-squamous NSCLC stopped early for efficacy:

http://finance.yahoo.com/news/checkmate-057-pivotal-phase-iii-125500524.html

Bristol-Myers Squibb Company today announced that an open-label, randomized Phase III study evaluating Opdivo (nivolumab) versus docetaxel in previously treated patients with advanced non-squamous non-small cell lung cancer (NSCLC) was stopped early because an assessment conducted by the independent Data Monitoring Committee (DMC) concluded that the study met its endpoint, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm.

Details such as the OS hazard ratio will be presented at an upcoming medical conference (presumably ASCO, if time permits).

Opdivo received FDA approval for second-line squamous NSCLC in Mar 2015 (#msg-111407710).