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Keytruda Gets FDA Approval for Pleural Mesothelioma


In the past, patients with inoperable pleural mesothelioma had few treatment options available. But a new Food and Drug Administration (FDA) approval for an immunotherapy drug means doctors have another choice. This approval follows a string of recent research breakthroughs.

In September 2024, the FDA approved the immunotherapy drug Keytruda® (pembrolizumab) combined with pemetrexed and platinum-based chemotherapy. This combination is cleared for first-line treatment of adult pleural mesothelioma patients with inoperable tumors.

The approval to treat mesothelioma partially stems from the KEYNOTE-483 clinical trial. Researchers found adding Keytruda to the chemo combination improved survival:

  • 17.3 months with Keytruda and chemotherapy
  • 16.1 months with chemotherapy only

A mesothelioma specialist can determine if this treatment is appropriate for an individual patient.

How Does Keytruda Work to Treat Mesothelioma?

Keytruda is a type of immunotherapy drug called an immune checkpoint inhibitor. These medicines empower the patient’s immune system to fight cancer. Keytruda allows immune cells to recognize and attack cancer cells. This approach has helped many mesothelioma patients already.

Keytruda joins other FDA-approved immunotherapy drugs for pleural mesothelioma. The combination of Opdivo® (nivolumab) and Yervoy® (ipilimumab) earned FDA approval in October 2020. It is now a standard treatment option.