Opdivo nivolumab regulatory update

FDA approved an sBLA from Bristol-Myers Squibb for Opdivo nivolumab expanding the melanoma indication for single-agent use and combination therapy with Yervoy ipilimumab. As a single agent for BRAF V600 mutation-positive, unresectable or metastatic melanoma, the agency removed the restriction that patients should have disease progression following Yervoy ipilimumab and a BRAF inhibitor. In combination with Yervoy for unresectable or metastatic melanoma, FDA removed the restriction for use only patients with BRAF wild-type melanoma.

Opdivo is now approved as a single agent for BRAF V600 wild-type unresectable or metastatic melanoma; and is under accelerated approval as a single agent for BRAF V600 mutation-positive, unresectable or metastatic melanoma and in combination with Yervoy for unresectable or metastatic melanoma. ...