FDA approvals

October 5, 2020

Drug Combo Approved for First-Line Treatment of Mesothelioma

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MONDAY, Oct. 5, 2020 -- On Friday, the U.S. Food and Drug Administration announced the approval of a drug combination for first-line treatment of unresectable malignant pleural mesothelioma (MPM) -- the first drug regimen to be approved for mesothelioma in 16 years.

The combined regimen of Opdivo (nivolumab) 360 mg every three weeks and Yervoy (ipilimumab) 1 mg/kg ever six weeks is now the second approved treatment for adults with MPM. According to the FDA, the combination of these monoclonal antibodies has been shown to decrease tumor growth by enhancing T-cell function.

Approval was based on data from the Phase 3 CheckMate-743 trial, a randomized, open-label trial of 605 patients with previously untreated unresectable MPM. Patients were randomly assigned to undergo up to six cycles of platinum-doublet chemotherapy or receive intravenous infusions of Opdivo every two weeks and intravenous infusions of Yervoy every six weeks for up to two years. Patients continued treatment until disease progression, unacceptable toxicity, or two years of completion. At a minimum follow-up of 22.1 months, median overall survival was 18.1 months for patients who received the Opdivo-Yervoy combination versus 14.1 months for patients who underwent chemotherapy. At two years, 41 and 27 percent of patients treated with the Opdivo-Yervoy combination and chemotherapy, respectively, were alive.

The most commonly reported side effects of the Opdivo-Yervoy combination included fatigue, musculoskeletal pain, rash, diarrhea, dyspnea, nausea, decreased appetite, cough, and pruritis. The FDA noted that Yervoy can also cause immune-mediated side effects, including pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis.

Approval was granted to Bristol-Myers Squibb.

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