First FDA nod for Keytruda in MPM
Pharma giant Merck & Co (NYSE: MRK) has announced that the US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), alongside pemetrexed and platinum chemotherapy, for the first-line treatment of adults with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).
This approval marks the first indication for Merck’s blockbuster anti-PD-1 therapy in MPM in the USA.
The authorization is based on results from the Phase III KEYNOTE-483 trial, in which Keytruda plus chemotherapy demonstrated a statistically significant improvement in overall survival versus chemotherapy alone.
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