FDA Approves Nivolumab Plus Ipilimumab for Previously Untreated Unresectable Malignant Pleural Mesothelioma.

The FDA approved nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. The approval was based on efficacy results from a pre-specified interim analysis from the open-label, multi-center, randomized phase 3 CHECKMATE 743 (NCT02899299) trial, designed to evaluate nivolumab plus ipilimumab compared with chemotherapy (pemetrexed and cisplatin or carboplatin) in patients with histologically confirmed unresectable MPM and no prior systemic therapy or palliative radiotherapy within 14 days of initiation of therapy.