Summary
- Pembrolizumab (Keytruda) with pemetrexed and platinum chemotherapy was FDA-approved for treating advanced malignant pleural mesothelioma.
- The combination treatment showed significant improvement in overall survival compared to chemotherapy alone.
- The recommended dose of pembrolizumab is 200 mg every 3 weeks or 400 mg every 6 weeks for up to 2 years.
- The FDA collaborated with international partners through Project Orbis for the review and approval process.
- Healthcare professionals should report adverse events related to the use of medicines through FDA’s MedWatch Reporting System.
In a groundbreaking move, the Food and Drug Administration (FDA) has approved pembrolizumab (Keytruda) in combination with pemetrexed and platinum chemotherapy as the first-line treatment for unresectable advanced or metastatic malignant pleural mesothelioma (MPM). This approval follows the successful results of a clinical trial that demonstrated a significant improvement in overall survival for patients receiving this combination therapy compared to those undergoing chemotherapy alone. The recommended dose of pembrolizumab is 200 mg every 3 weeks or 400 mg every 6 weeks for up to 2 years, or until disease progression or unacceptable toxicity.
The FDA’s approval of pembrolizumab with chemotherapy for MPM is part of Project Orbis, an initiative that allows for the simultaneous review of oncology drugs among international regulatory partners. The application for this approval was granted priority review, showcasing the importance of this treatment option for patients with MPM. Healthcare professionals are advised to report any serious adverse events associated with this treatment to the FDA’s MedWatch Reporting System. Overall, this approval marks a significant advancement in the treatment options available for individuals diagnosed with MPM.
Oncology,Pulmonary MedicineFDA, approves, pembrolizumab, chemotherapy, unresectable, advanced, metastatic, malignant pleural mesothelioma