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DewDiligence

04/21/17 2:26 PM

#210770 RE: DewDiligence #208684

CHMP approves Opdivo monotherapy for second/third-line bladder cancer:

http://finance.yahoo.com/news/bristol-myers-squibb-receives-positive-180600779.html

This approval is based on the single-arm phase-2 CHECKMATE-027 study (#msg-125671046), and it is not restricted by PD-L1 expression.

This is the CHMP’s first PD-(L)1 approval in this indication. In the US, Opdivo and Roche’s Tecentriq have accelerated approval in this indication (#msg-128386168, #msg-130552759).