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Merck: new request for Keytruda

(CercleFinance.com) - Merck has announced that the US Food and Drug Administration (FDA) has granted priority review to an application for an additional biological license for its Keytruda based on the results of the Keynote-189 Phase III trial.


This submission requests the approval of this drug in combination with pemetrexed (Alimta) and platinum chemotherapy as a first-line treatment for non-squamous metastatic non-small cell lung cancer (NSCLC).

The pharmaceuticals group says the US health authorities have granted a priority review to its application for a biological license and have set 23 September as the date when they rule on the case.

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