FDA Approves Opdivo (nivolumab) Plus Yervoy (ipilimumab) as First-Line Immunotherapy for Unresectable Malignant Pleural Mesothelioma

The U.S. FDA Approves the Combination Therapy of Opdivo (nivolumab) and Yervoy (ipilimumab) for First-Line Treatment of Adult Patients with Unresectable Malignant Pleural Mesothelioma. This is the first drug therapy approved for mesothelioma in 16 years, and it is alsoFDAThe Second Approved Systemic Therapy for Mesothelioma.

The vast majority of mesotheliomas are malignant pleural mesothelioma (MPM), a type of cancer affecting the lining of the lungs caused by inhalation of asbestos fibers. In the United States, approximately 20,000 cases are diagnosed annually, and most patientsDiagnosisTime,TumorThese tumors are no longer resectable. For these patients, currently available therapies have shown limited efficacy, and overall survival outcomes remain poor.

Opdivo and Yervoy, as cancer immunotherapies, target PD-1 and CTLA-4, respectively. When used in combination, they are expected to enhance T-cell function and inhibitTumorgrowth.

In a randomized, open-labelClinical TrialsAmong them, 605 patients were previously untreated,TumorIn patients with unresectable malignant pleural mesothelioma (MPM), this immunotherapy combination was administered to determine whether it could improve overall survival compared with chemotherapy. The analysis showed that the median overall survival was 18.1 months in patients receiving the combination therapy, versus 14.1 months in those receiving chemotherapy.

FDADirector of the Center for Excellence in Oncology andTumorDr. Richard Pazdur, Acting Director of the Office of Oncologic Diseases, stated, “The approval today of the combination of nivolumab and ipilimumab provides an innovative treatment option that can improve overall survival in patients with malignant pleural mesothelioma.”Bio ValleyBioon.com）