Posted by Michael Wonder on 16 Sep 2020
EMA validates Bristol Myers Squibb’s type II variation application for Opdivo (nivolumab) plus Yervoy (ipilimumab) for first-line treatment of malignant pleural mesothelioma
15 September 2020 - Opdivo plus Yervoy would potentially be the first immunotherapy option for the first-line treatment of this cancer with high unmet needs.
Bristol Myers Squibb today announced that the EMA validated a type II variation application for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the treatment of patients with previously untreated, unresectable malignant pleural mesothelioma. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.
The type II variation application is supported by data from the pivotal Phase 3 CheckMate-743 trial, which met the primary outcome of superior overall survival with Opdivo plus Yervoy versus chemotherapy (pemetrexed and cisplatin or carboplatin) in all randomised patients.
