Bristol-Myers Squibb obtains FDA OK for Opdivo in combination with Yervoy

The Food and Drug Administration gave Bristol-Myers Squibb its stamp of approval for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of adults with malignant pleural mesothelioma that cannot be removed by surgery. This is the first drug regimen approved for mesothelioma in 16 years and the second FDA approved systemic therapy for mesothelioma.

"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, 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.

"In 2004, FDA approved pemetrexed in combination with cisplatin for this indication, and now patients have an important, additional treatment option after more than a decade with only one FDA approved drug regimen," said Pazdur.

Malignant pleural mesothelioma is a life-threatening cancer of the lungs' lining caused by inhaling asbestos fibers that about 20,000 Americans are diagnosed with each year. MPM accounts for most mesothelioma diagnoses, and most patients have an unresectable (unable to be removed with surgery) tumor at time of diagnosis. With currently available therapy, overall survival is generally poor. Opdivo and Yervoy are both monoclonal antibodies that, when combined, decrease tumor growth by enhancing T-cell function.