FDA accepts sBLA for Opdivo+Yervoy regimen in patients with previously untreated advanced melanoma

Bristol-Myers Squibb Company has announced that the US Food and Drug Administration (FDA) has accepted for filing and review the supplemental Biologics License Application (sBLA) for Opdivo+Yervoy regimen in patients with previously untreated advanced melanoma.

The FDA also granted Priority Review for this application. The projected FDA action date is 30 September 2015. This is the first regulatory milestone for an immuno-oncology regimen in cancer.

Opdivo+Yervoy regimen demonstrated greater efficacy beyond standard of care for patients with advanced melanoma

This new sBLA accepted by the FDA includes data from CheckMate -069, the first randomised trial evaluating the Opdivo+Yervoy regimen in patients with previously untreated advanced melanoma. In the trial, patients with BRAF wild-type mutation status treated with the regimen experienced improved objective response rate as compared to patients administered Yervoy monotherapy. The Opdivo+Yervoy regimen achieved an objective response rate of 61%, including a 22% complete response rate, in previously untreated advanced melanoma patients. The safety profile also was consistent with previously-reported studies evaluating the Opdivo+Yervoy regimen.

“Our strategy has always been to bring forth combination regimens of our Immuno-Oncology medicines to help bring the potential of long-term survival to patients,” said Michael Giordano, senior vice president, Head of Development, Oncology, Bristol-Myers Squibb. “The Opdivo+Yervoy regimen, in the CheckMate -069 trial, demonstrated greater efficacy beyond standard of care for patients with advanced melanoma.”