FDA official announcements and press releases

Merck's Subcutaneous Keytruda with Berahyaluronidase Alfa Meets Primary Endpoints in Phase 3 Trial

Nov 19, 2024, 12:59 PM

Merck announced on Tuesday that a Phase 3 trial of a subcutaneous version of its blockbuster cancer drug Keytruda, combined with Berahyaluronidase Alfa, met its primary endpoints. The study demonstrated that the injectable formulation of Keytruda is not inferior to the currently approved intravenous version, showing similar blood levels of the drug. This new formulation is expected to make Keytruda more accessible and easier to administer, potentially extending the drug’s sales. The announcement comes a decade after Keytruda hit the market, following Roche's recent FDA approval for a subcutaneous PD-L1-targeting drug.