On Oct. 1, 2020, the FDA approved 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.

The FDA granted approval to Bristol-Myers Squibb Company. This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence.