FDA gives first new approval for mesothelioma in 16 years

Oct. 6, 2020

The FDA has given the green light to a treatment combo for mesothelioma, a malignant tumor associated with asbestos inhalation.

The Opdivo/Yervoy combo from Bristol Myers Squibb was approved as a first-line treatment for the tumor when it cannot be removed with surgery, and is the first new treatment OK’d by the agency in 16 years. The FDA based its approval on a trial showing that the combo of Opdivo, a PD-1 antibody, and Yervoy, a CTLA4 inhibitor, improved the median survival time from 14.1 months on chemotherapy to 18.1 months. It is the fourth FDA approval for the drug combo this year.

But the good news came on a day of mixed results for BMS. 

In a separate study, the Opdivo/Yervoy combo failed to extend the lives of patients with stage 3 or 4 melanoma compared to Opdivo alone. 

BMS has been exploring the use of dual immunotherapies as a way for patients with certain types of cancer to avoid chemo. Despite the setback in melanoma, the company said that the study at least “reinforced the established benefit of Opdivo monotherapy as a standard of care in the adjuvant setting."