FDA

FDA Approves New Mesothelioma Combination

The FDA has approved the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for the first-line treatment of adults with malignant pleural mesothelioma (MPM) that is untreatable with surgery.

The combination was approved following a randomized, open-label trial involving 605 patients with untreated unrespectable MPM who received intravenous infusions of Opdivo every 2 weeks and of Yervoy every 6 weeks for up to 2 years, or chemotherapy for up to 6 cycles.

Overall, patients treated with the drug combination survived for a median of 18.1 months compared with 14.1 months in patients treated with chemotherapy.

The most common side effects included fatigue, musculoskeletal pain, rash, diarrhea, dyspnea, nausea, decreased appetite, cough and pruritis.

—Michael Potts

Reference:

FDA Approves Drug Combination for Treating Mesothelioma. News release. US Food and Drug Administration. October 2, 2020. Accessed October 5, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-drug-combination-treating-mesothelioma