U.S. Food and Drug Administration (FDA) has accepted BMS's filing and review a supplemental Biologics License Application (sBLA) for the Opdivo (nivolumab)+Yervoy (ipilimumab) regimen to include clinical data from CheckMate -067, a landmark trial in patients with previously untreated advanced melanoma. The FDA also granted Priority Review for this application with a target action date of January 23, 2016.
CheckMate -067 is the first Phase 3 trial evaluating the Opdivo+Yervoy regimen or Opdivo monotherapy vs. Yervoy monotherapycccc in patients with previously untreated advanced melanoma. Results from CheckMate -067 demonstrated superior progression-free survival (PFS) for the Opdivo + Yervoy regimen or Opdivo monotherapy vs. Yervoy monotherapy in previously untreated patients with advanced melanoma, regardless of BRAF status. If approved, this application would expand upon the initial application for the Opdivo+Yervoy regimen, which was based on tumor response rate and safety data from the Phase 2 randomized trial, CheckMate -069. The CheckMate -067 trial that serves as the basis for this submission includes comparative PFS and objective response rate data.
“Findings from CheckMate -067 provide additional evidence that the combination of two Immuno-Oncology agents, Opdivo and Yervoy, may provide improved outcomes for patients with advanced melanoma, and has the potential to become the basis for how this devastating disease is treated,” said Michael Giordano, senior vice president, head of Development, Oncology, Bristol-Myers Squibb. “We saw significant clinical benefit from the Opdivo+Yervoy regimen in these patients, including an increase in the time patients lived without disease progression, and we look forward to working with the FDA to review this data.”
The CheckMate -067 trial is ongoing and patients continue to be followed for the co-primary endpoint of overall survival.
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