Posted by Michael Wonder on 28 May 2023
Bristol Myers Squibb receives positive CHMP opinion recommending approval for Opdivo (nivolumab) with chemotherapy as neo-adjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in patients with tumour cell PD-L1 expression ≥1%
26 May 2023 - Recommendation based on results from the Phase 3 CheckMate-816 trial, in which Opdivo with chemotherapy demonstrated improved event-free survival and pathologic complete response compared to chemotherapy alone when administered before surgery.
BMS today announced that the CHMP of the EMA has recommended approval of Opdivo (nivolumab) in combination with platinum-based chemotherapy for the neo-adjuvant treatment of resectable non-small cell lung cancer at a high risk of recurrence in adult patients with tumour cell PD-L1 expression ≥1%.
