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FDA Approves KEYTRUDA® (pembrolizumab) Plus Pemetrexed and Platinum Chemotherapy as First-Line Treatment for Patients with Unresectable or Metastatic Malignant Pleural Mesothelioma

For patients with MPM (Malignant Pleural Mesothelioma), the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab) as a first-line treatment when combined with pemetrexed and platinum-based chemotherapy.

Keytruda(pembrolizumab) is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD- L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

The FDA’s approval of this treatment was based on the results of the Phase 2/3KEYNOTE-483 trial. Keytruda plus chemotherapy demonstrated a statistically significant improvement in overall survival (OS), reducing the risk of death by 21% (HR=0.79 [95% CI, 0.64-0.98]; p=0.0162) compared to chemotherapy alone. In addition, the Overall Response Rate(ORR) was shown to be 52% for the Keytruda with chemotherapy compared to 29% for chemotherapy alone.

This opens an additional therapy option for a cancer with few approved treatments.

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