BMS Reports EMA’s Validation of MAA for Relatlimab and Nivolumab as 1L Treatment for Unresectable or Metastatic Melanoma

October 1, 2021 Auto Bot BMS, EMA, MAA, Nivolumab, regulatory 0

Shots:

  • The MAA was based on the efficacy & safety results from the P-II/III RELATIVITY-047 trial that evaluates the fixed-dose combination of relatlimab (160mg) + nivolumab (480mg) vs Opdivo (480mg, IV, q4w) alone in a ratio (1:1) in 714 patients aged ≥12yrs. with previously untreated metastatic or unresectable melanoma
  • The results demonstrated an improvement in PFS of combination therapy over SoC & follow-up for 2EPs of OS & ORR is ongoing. The results were presented at ESMO 2021
  • With the validation, the application is complete & the EMA will now initiate the review procedure. The US FDA has also accepted the BLA for priority review of the fixed-dose combination

Click here to­ read full press release/ article | Ref: Businesswire | Image: Fierce Pharma

The post BMS Reports EMA’s Validation of MAA for Relatlimab and Nivolumab as 1L Treatment for Unresectable or Metastatic Melanoma first appeared on PharmaShots.