Supplemental biologics license application for Opdivo plus Yervoy regimen in patients with previously untreated advanced melanoma
Bristol-Myers Squibb ( BMS ) has announced that the FDA ( Food and Drug Administration ) has accepted for filing and review the supplemental Biologics License Application ( sBLA ) for Opdivo ( Nivolumab ) + Yervoy ( Ipilimumab ) regimen in patients with previously untreated advanced melanoma.
The FDA also granted Priority Review for this application.
This new sBLA accepted by the FDA includes data from CheckMate -069, the first randomized trial evaluating the Opdivo plus 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 plus 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 plus Yervoy regimen.
Opdivo and Yervoy are both monoclonal antibodies and immune checkpoint inhibitors that target separate, distinct checkpoint pathways. Inhibition of these immune checkpoint pathways results in enhanced T cell function greater than the effects of either antibody alone.
Opdivo became the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world on July 4, 2014 when Ono Pharmaceutical Co. announced that it received manufacturing and marketing approval in Japan for the treatment of patients with unresectable melanoma.
In the U.S., the FDA granted its first approval for Opdivo for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy and, if BRAF V600 mutation positive, a BRAF inhibitor.
On March 4, 2015, Opdivo received its second FDA approval for the treatment of patients with metastatic squamous non-small cell lung cancer with progression on or after Platinum-based chemotherapy.
On March 25, 2011, the FDA approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. ( Xagena )
Source: Bristol-Myers Squibb, 2015