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Keytruda NSCLC Approval Will Test PD-L1 Expression

 
• By Emily Hayes

Labeling is specific for those with PD-L1 expression as measured with a new companion diagnostic and does not reference data for PD-L1 negative patients.

FDA’s approval of Merck & Co. Inc.’s Keytruda (pembrolizumab) in non-small cell lung cancer marks a turning point in development for the family of programmed death inhibitors in that it is the first approval targeted for patients with PD-L1 expression, measured with a new companion diagnostic.

On Oct. 2, the agency granted accelerated approval for Keytruda for patients with advanced (metastatic) NSCLC whose disease has progressed...

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