Search
BMY:US Opdivo approved in 2L non-squamous lung without mandatory PD-L1 testing, but FDA label challe
The FDA approved in 2nd line lung cancer for Bristol-Myers’ Opdivo and Merck’s Keytruda. The headline is of course that the FDA did not restrict Opdivo’s use by PD-L1 status. Theoretically Opdivo can be prescribed to all 2nd line NSCLC pts. However amongst other things, the label does also clearly show that Opdivo is not better than chemo in the 64% of patients who express <10% PD-L1 cells...
