FDA Approves Keytruda for First-Line Treatment of Malignant Pleural Mesothelioma

FDA Approval:
The U.S. Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma (MPM) in adults.

Clinical Trial Results:
The approval is based on the Phase 3 CCTG IND.227/KEYNOTE-483 trial, which showed that Keytruda plus chemotherapy significantly improved overall survival (OS) compared to chemotherapy alone, reducing the risk of death by 21%.

Efficacy Data:
The median OS for patients receiving Keytruda plus chemotherapy was 17.3 months, compared to 16.1 months for those treated with chemotherapy alone. The combination therapy also improved progression-free survival (PFS) and had a higher overall response rate (ORR) of 52%, compared to 29% for chemotherapy alone.

Market Impact:
This approval potentially unlocks a $12 billion market opportunity for Merck, according to recent estimates.

Disease Background:
Malignant pleural mesothelioma is a rare and aggressive form of cancer that develops in the lining of the lungs and chest cavity, with generally poor prognoses.

Side Effects:
Adverse effects experienced by MPM patients were consistent with those seen in other patients treated with Keytruda in combination with pemetrexed and platinum chemotherapy.