Positive new data on Keytruda, as Merck files for lung cancer approval

20 April 2015

US pharma giant Merck & Co (NYSE:MRK) says it has submitted a supplemental Biologics License Application to the US Food and Drug Administration for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of advanced non-small cell lung cancer (NSCLC).

Keytruda is already approved in the USA to treat advanced melanoma. Merck also said that a premarket approval application was also submitted by Agilent Technologies' Dako unit for an immunohistochemistry companion diagnostic test, PD-L1 IHC 22C3 PharmDx, which detects PD-L1 expression.

Blockbuster sales potential

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