FDA Priority Review for Opdivo/Yervoy Combo in Skin Cancer

Monday, June 1, 2015

Source: Pharma Times

US regulators have agreed to review a supplemental filing for Bristol-Myers Squibb’s combination of immunotherapies Opdivo and Yervoy in patients with previously untreated advanced melanoma.

The US Food and Drug Administration has assigned the application a priority review, on the back of data (from CheckMate-069) showing that the Opdivo (nivolumab)/Yervoy (ipilimumab) regimen achieved tumour shrinkage in 61% of patients and a complete response in 22%.

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