ARTICLE | Clinical News

Opdivo nivolumab regulatory update

October 5, 2015 7:00 AM UTC

Bristol-Myers Squibb said FDA granted accelerated approval of BMS’s Yervoy ipilimumab plus Opdivo nivolumab to treat BRAF V600 wild-type unresectable or metastatic melanoma. The approval is based on the Phase II CheckMate -069 trial (see BioCentury, April 27). BMS said 4 doses of Opdivo plus Yervoy would cost about $141,000 and that standard administration includes 4 doses of the combination followed by Opdivo monotherapy until disease progression. Opdivo, a human IgG4 mAb against PD-1, costs $12,500 per month. Yervoy is a human mAb against CTLA-4 receptor.

The combination is also under FDA review to treat patients with previously untreated advanced melanoma, with a Nov. 27 PDUFA date. Yervoy is approved in the U.S. to treat unresectable or metastatic melanoma. Opdivo has accelerated approval in the U.S. to treat patients with unresectable or metastatic melanoma and disease progression following treatment with Yervoy and, if BRAF V600 mutation-positive, a BRAF inhibitor. Opdivo is also approved in the U.S. to treat metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy and under FDA review to treat non-squamous NSCLC in previously treated patients, with a PDUFA date of Jan. 2, 2016. ...