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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 after other treatments and with tumors that express PD-L1. The...

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