Posted by Michael Wonder on 28 Feb 2023
US FDA accepts Bristol Myers Squibb’s supplemental biologics license application and EMA validates application for Opdivo (nivolumab) as an adjuvant treatment for patients with completely resected stage IIB or IIC melanoma
28 February 2023 - The applications are based on results from the Phase 3 CheckMate-76K trial, in which Opdivo demonstrated a statistically significant and clinically meaningful benefit in recurrence-free survival.
Bristol Myers Squibb today announced that the US FDA has accepted the supplemental biologics license application and the EMA has validated the type II variation marketing authorisation application for Opdivo (nivolumab) as monotherapy in the adjuvant setting for the treatment of patients with completely resected stage IIB or IIC melanoma.
