Posted by Michael Wonder on 20 Sep 2021
U.S. Food and Drug Administration accepts for priority review Bristol Myers Squibb’s application for LAG-3-blocking antibody relatlimab and nivolumab fixed dose combination as treatment for patients with unresectable or metastatic melanoma
20 September 2021 - The application is based on Phase 2/3 RELATIVITY-047 trial, in which the relatlimab and nivolumab fixed-dose combination demonstrated a statistically significant and clinically meaningful progression-free survival benefit over Opdivo monotherapy.
Bristol Myers Squibb today announced that the U.S. FDA has accepted for priority review the biologics license application for the LAG-3-blocking antibody relatlimab and nivolumab fixed-dose combination, administered as a single infusion, for the treatment of adult and pediatric patients (12 years and older and weighing at least 40 kg) with unresectable or metastatic melanoma.
The FDA assigned a Prescription Drug User Fee Act goal date of 19 March 2022.
