ARTICLE | Clinical News

Opdivo nivolumab regulatory update

December 7, 2015 8:00 AM UTC

FDA approved sBLAs from Bristol-Myers Squibb for Opdivo nivolumab to treat advanced renal cell carcinoma (RCC) and BRAF V600 wild-type melanoma but issued a complete response letter for an sBLA seeking approval for previously untreated melanoma. Opdivo is now indicated in RCC patients who have received prior anti-angiogenic therapy and as single agent to treat BRAF V600 wild-type unresectable or metastatic melanoma.

In the complete response letter, BMS said FDA requested additional data in the BRAF-mutated population. The pharma had submitted the sBLA seeking approval of Opdivo as a single agent for previously untreated metastatic melanoma based on data from the Phase III CheckMate -066 trial, which compared Opdivo vs. dacarbazine in BRAF wild-type advanced melanoma, and data in BRAF V600 mutation-positive metastatic melanoma. BMS said it is working with the agency to determine whether additional data, which are under review, adequately address the request. ...