FDA Approves Nivolumab, Ipilimumab Combo for First-Line Mesothelioma Treatment


Nivolumab plus ipilimumab decreased tumor growth in patients with untreated unresectable malignant pleural mesothelioma.


The FDA has approved nivolumab (Opdivo; Bristol-Myers Squibb Company) in combination with ipilimumab (Yervoy; Bristol-Myers Squibb Company) for the first-line treatment of adults with malignant pleural mesothelioma (MPM) that cannot be removed through surgery.

The FDA’s review of the combination treatment was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence, and partnered with the Australian Therapeutics Goods Administration (TGA), the Brazilian Health Regulatory Agency (ANVISA), Health Canada, and Switzerland’s Swissmedic.

The approval, which arrived about 5 months ahead of the goal date, marks the first approved drug regimen in 16 years for mesothelioma; the previous approval occurred in 2004. According to the FDA, treatments for MPM that have been available demonstrate generally poor overall survival (OS).

MPM is a cancer within the lining of the lungs caused by asbestos inhalation; approximately 20,000 Americans are diagnosed with MPM each year. The majority of individuals with MPM have an unresectable tumor at the time of their diagnosis.

The agency’s approval is based on a randomized, open-label clinical trial that incorporated 605 patients with previously untreated unresectable MPM. Patients were administered intravenous (IV) infusions of nivolumab every 2 weeks and IV infusions of ipilimumab every 6 weeks for up to 2 years, and were compared against participants receiving platinum-doublet chemotherapy for up to 6 cycles. Investigators of the trials reported that patients receiving combination therapy of nivolumab and ipilimumab showed a median OS of 18.1 months; patients who underwent chemotherapy survived a median of 14.1 months.

The most common adverse effects of the combination therapy in patients with MPM include fatigue, musculoskeletal pain, rash, diarrhea, dyspnea, nausea, decreased appetite, cough, and pruritis.

“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 Richard Pazdur, MD, 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. “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 1 FDA-approved drug regimen.”


  1. FDA Approves Drug Combination for Treating Mesothelioma. News Release. FDA; October 2, 2020. Accessed October 5, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-drug-combination-treating-mesothelioma.

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