Merck: FDA grants priority review to Keytruda

(CercleFinance.com) - US health regulators granted a priority review for Merck's Keytruda for the treatment of metastatic non-small cell lung cancer, potentially accelerating the immunotherapy's route to market.


It is estimated that a priority review takes several months rather than around one year usually for the other applications accepted by the FDA.

The FDA has set a target action date of 11 January 2019.

The FDA's decision applies to patients with locally advanced or metastatic non-squamous or squamous non-small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 without EGFR or ALK genomic tumor aberrations.

Merck's Keytruda works by increasing the body's immune system's ability to help detect and fight tumor cells.

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