Why wait? FDA gives early OK to Merck’s Keytruda for frontline lung cancer
That didn’t take long.
Two weeks after Merck $MRK made a triumphant victory march against Bristol-Myers Squibb on the frontline non-small cell lung cancer front at ESMO, the FDA has followed up with a crucial approval for the early use of its checkpoint inhibitor Keytruda.
The agency green-lighted the use of Keytruda among high expressers of PD-L1, one of the key instruments that cancer cells use to deflect an attack by T cells. The FDA had set the PDUFA date on this sBLA for Christmas Eve, but regulators are moving much faster than the normal timelines permit when it comes to the established checkpoint drugs.
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