Posted by Michael Wonder on 21 Sep 2020
Bristol Myers Squibb receives positive CHMP opinion recommending approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) combined with two cycles of chemotherapy as first-line treatment of metastatic non-small cell lung cancer
18 September 2020 - Application based on results from the Phase 3 CheckMate -9LA trial, which showed significantly improved overall survival in previously untreated patients with metastatic non-small cell lung cancer.
Bristol Myers Squibb today announced that the CHMP of the EMA has recommended approval of Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of platinum-based chemotherapy for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation.
The European Commission, which has the authority to approve medicines for the European Union, will now review the CHMP recommendation.
