FDA gives Merck ‘real-time’ OK for Keytruda, offering a peek at the latest extension of the agency's data express highway
The FDA doesn’t always wait for a marketing application to come in before it begins its review these days. And that suits Merck just fine.
The federal agency has stamped a full approval — following last year’s conditional OK — on Merck’s mega-blockbuster Keytruda for frontline use in a chemo combo for fighting non-squamous non-small cell lung cancer. Regulators based their decision on the data set from KEYNOTE-189, put on display last April, one in a series of late-stage trials that Merck has been rolling out to grab the lead on the PD-1/L1 market from a group of tough competitors at Bristol-Myers Squibb.
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