FDA Accepts BMS’ sBLA for Combo Immunotherapy

The US Food and Drug Administration (FDA) has accepted for filing and review Bristol-Myers Squibb’s 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. The projected FDA action date is September 30, 2015.

This new sBLA accepted by the FDA includes data from CheckMate -069, the first randomized trial evaluating the Opdivo+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+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+Yervoy regimen.

Cancer cells may exploit “regulatory” pathways, such as checkpoint pathways, to hide from the immune system and shield the tumor from immune attack. 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.

In the US, the FDA granted its first approval for Opdivo for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor in 2014. In March 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. In 2011, the FDA approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is now approved in more than 40 countries.

Source: Bristol-Myers Squibb

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