Bristol Myers Squibb (BMY)

[DewDiligence]

BMY withdraws EU application based on CHECKMATE-227 study:

https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-withdraws-european-application-opdivo-niv

Though the Committee for Medicinal Products for Human Use (CHMP) acknowledged the integrity of the patient level data, the CHMP determined a full assessment of the application was not possible following multiple protocol changes the company made in response to rapidly evolving science and data. The company has no plans to refile this application in the EU.

Can't fault the CHMP for saying CM_227 was too convoluted to evaluate.

The US sBLA based on the same CHECKMATE-227 data is (somewhat surprisingly, IMO) under review by the FDA with a PDUFA date of 5/15/20 (#msg-153308881).

Note: The CHECKMATE-9LA study, in which the Opdivo/Yeryoy arm included two cycles of induction chemotherapy (#msg-151836584) will be part of separate applications (i.e. distinct from CHECKMATE-227) in both the US and EU. This is confirmed in the above PR.