FDA Approves Drug Combination To Treat Mesothelioma

(RTTNews) - The Food and Drug Administration approved a combination of Opdivo (nivolumab) and Yervoy (ipilimumab) on October 2, for the first-line treatment of malignant pleural mesothelioma that cannot be removed by surgery.

Developed by Bristol Myers Squibb (BMY), this two-drug regimen becomes the first therapy approved by the FDA in 16 years for malignant pleural mesothelioma (MPM).

Malignant pleural mesothelioma, a type of lung cancer caused by inhaling asbestos fibers, affects the tissues surrounding the lungs with symptoms including shortness of breath, dry cough, and chest pain. Every year, nearly 20,000 people are diagnosed with this disease in the U.S.

"Malignant pleural mesothelioma is a rare cancer with limited treatment options. When it is diagnosed in advanced stages, the five-year survival rate is approximately 10 percent," said study investigator Anne S. Tsao, M.D., professor and Section Chief Thoracic Medical Oncology and Director of the Mesothelioma Program at The University of Texas M.D. Anderson Cancer Center.

This is the third indication approved for the Opdivo + Yervoy combination therapy in the first-line treatment of a form of thoracic cancer. In May this year, the FDA had approved Opdivo + Yervoy to treat Non-Small Cell Lung Cancer.

"Today's approval of nivolumab plus ipilimumab provides a new treatment that has demonstrated an improvement in overall survival for patients with malignant pleural mesothelioma," said Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA's Center for Drug Evaluation and Research.

Eli Lilly's pemetrexed in combination with cisplatin, approved in 2004, is the other treatment approved by the FDA for malignant pleural mesothelioma.