FDA approves Opdivo + Yervoy for first-line use in MPM

The US Food and Drug Administration has approved Opdivo (nivolumab) + Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM). With this approval, the combination becomes the first new systemic therapy in over 15 years to be approved by the FDA in this setting.

This approval for US pharma major Bristol Myers Squibb (NYSE: BMY) marks the third indication for Opdivo + Yervoy-based treatments in thoracic cancers and the seventh indication overall.

“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 Dr 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, adding: “In 2004, FDA approved pemetrexed in combination with cisplatin for this indication, and now patients now have an important, additional treatment option after more than a decade with only one FDA-approved drug regimen.”