FDA bars the door — for now — against Merck’s star cancer drug after Roche beat them to the...

Discussion in 'Pharma/Biotech Companies - In the News' started by cafead, Jul 8, 2020 at 11:12 AM.

  1. #1 cafead, Jul 8, 2020 at 11:12 AM
    cafead

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    via Merck has been handed a rare setback at the FDA.

    After filing for the accelerated approval of a combination of their star PD-1 drug Keytruda with Eisai’s Lenvima as a first-line treatment for unresectable hepatocellular carcinoma, the FDA nixed the move, handing out a CRL because Roche beat them to the punch on the same indication by a matter of weeks.

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