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BMS’ Opdualag (nivolumab and relatlimab-rmbw) Receives the US FDA’s Approval for the Treatment of Unresectable or Metastatic Melanoma

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BMS’ Opdualag (nivolumab and relatlimab-rmbw) Receives the US FDA’s Approval for the Treatment of Unresectable or Metastatic Melanoma

BMS’ Opdualag (nivolumab and relatlimab-rmbw) Receives the US FDA’s Approval for the Treatment of Unresectable or Metastatic Melanoma

Shots:

  • The approval was based on the P-II/III (RELATIVITY-047) trial to evaluate relatlimab (160mg) + nivolumab (480mg) vs Opdivo (480mg, IV, q4w) alone in a ratio (1:1) in 714 patients aged ≥12yrs. with unresectable or metastatic melanoma
  • The trial met its 1EPs i.e., improvement in PFS with m-PFS (10.1mos. vs 4.6mos.). The safety profile was similar to that previously reported for nivolumab with no new safety events, grade 3/4 drug-related AEs (18.9% vs 9.7%), treatment discontinuation due to AEs (14.6% vs 6.7%) & the combination resulted in increased T-cell activation
  • Opdualag is the fixed-dose combination of nivolumab & relatlimab. The application has been approved under the US FDA’s RTOR pilot program

Ref: Bristol Myers Squibb | Image: BMS

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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