FDA Approves Nivolumab-Ipilimumab Combo for Malignant Pleural Mesothelioma
The US Food and Drug Administration has approved nivolumab (Opdivo; Bristol-Myers Squibb Company) in combination with ipilimumab for first-line treatment of adults with unresectable malignant pleural mesothelioma.
This is the first FDA approval for mesothelioma in 16 years and the second FDA-approved systemic therapy for mesothelioma.
This approval was based on a randomized, open-label trial, in which 605 patients with previously untreated unresectable malignant pleural mesothelioma were enrolled to receive intravenous infusions of nivolumab every two weeks with ipilimumab infusions every six weeks for up to two years, or to receive platinum-doublet chemotherapy for up to six cycles.
The endpoint was to determine if the nivolumab-ipilimumab combo improved overall survival compared to chemotherapy. Patients who received the combination had a median OS of 18.1 months compared to 14.1 months for chemotherapy.
Fatigue, musculoskeletal pain, rash, diarrhea, dyspnea, nausea, decreased appetite, cough and pruritis were the most common side effects.
Ipilimumab can cause immune-mediated side effects including inflammation of healthy organs (lung, colon, liver, endocrine glands, and kidneys).
This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence, and occurred approximately 5 months ahead of the goal date.—Kaitlyn Manasterski
Source: US Food and Drug Administration. FDA Approves Drug Combination for Treating Mesothelioma. October 2, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-drug-combination-treating-mesothelioma. Accessed October 5, 2020.
