FDA Approves Keytruda and Chemotherapy for Unresectable Advanced Malignant Pleural Mesothelioma
FDA Approval: Keytruda Plus Chemotherapy
The Food and Drug Administration (FDA) has authorized use of Keytruda (pembrolizumab) in combination with pemetrexed and platinum chemotherapy as a first-line treatment for patients with unresectable advanced or metastatic malignant pleural mesothelioma.
Significance of KEYNOTE-483 Trial Findings
This significant approval stems from the findings of the KEYNOTE-483 trial. The trial focused on patients diagnosed with unresectable, advanced malignant pleural mesothelioma who had not received prior systemic treatment. Random assignments were made for patients to either receive Keytruda alongside chemotherapy for two years or only the chemotherapy regimen.
- Overall survival increased to 17.3 months for the Keytruda group compared to 16.1 months for chemotherapy alone.
- The confirmed response rate for patients on the Keytruda regimen was 52%, against 29% for those receiving only chemotherapy.
- Side effects noted were consistent with previous reports, with severe and life-threatening complications occurring in 27% of the Keytruda group.
The study highlighted standard treatment for malignant pleural mesothelioma involves platinum-pemetrexed chemotherapy, making this combination therapy a vital advancement for enhancing patient care.
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