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).