FDA Grants Priority Review for Opdivo/Yervoy Melanoma Regimen
Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to the supplemental Biologics License Application (sBLA) for the Opdivo (nivolumab) + Yervoy (ipilimumab) regimen to include clinical data from the CheckMate -067 trial of patients with previously untreated advanced melanoma.
CheckMate -067 is an ongoing trial and the first Phase 3 study evaluating the Opdivo+Yervoy regimen or Opdivo monotherapy vs. Yervoy monotherapy in patients with previously untreated advanced melanoma. Results from CheckMate -067 demonstrated superior progression-free survival (PFS) for the Opdivo+Yervoy regimen, regardless of BRAF status. The sBLA submission includes comparative PFS and objective response rate data from CheckMate -067.
Opdivo, a programmed death-1 (PD-1) immune checkpoint inhibitor, and Yervoy, a cytotoxic T-lymphocyte antigen 4 (CTLA-4) inhibitor, are both monoclonal antibodies that target separate, distinct checkpoint pathways.
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