The U.S. Food and Drug Administration has approved nivolumab (Opdivo; Bristol-Myers Squibb) 360 mg every 3 weeks plus ipilimumab (Yervoy; Bristol-Myers Squibb) 1 mg/kg every 6 weeks for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma, according to a press release.
Approval was based on a pre-specified interim analysis from the Phase 3 CheckMate -743 trial. In the trial, 303 patients treated with nivolumab plus ipilimumab demonstrated superior overall survival (OS) versus the 302 patients treated with platinum-based standard of care chemotherapy (median OS of 18.1 months vs 14.1 months, respectively) after 22.1 months of minimum follow-up. After 2 years, 41% of patients on the combination treatment were alive compared with 27% of patients receiving chemotherapy.
“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, M.D., 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 one FDA-approved drug regimen.”
Read the full press release here.