07:20 AM EDT, 09/18/2024 (MT Newswires) -- Merck ( MRK ) said Wednesday that the US Food and Drug Administration has approved Keytruda's combination with emetrexed and platinum chemotherapy as first-line treatment for adult patients with unresectable advanced or metastatic malignant pleural mesothelioma.
The company said the approval was based on data from a phase 2/3 trial, where the combination therapy demonstrated a "statistically significant improvement" in overall survival compared with treatment with chemotherapy alone.
Merck ( MRK ) said the new approval serves as Keytruda's first indication in malignant pleural mesothelioma in the US.
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