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

2 June 2015  •  Author: Victoria White

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.

bms-opdivo+yervoy

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.”

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