FDA Accepts Filing for BMS’ Combo Immunotherapy

The US Food and Drug Administration (FDA) has accepted for filing and review a supplemental biologics license application (sBLA) for the Opdivo (nivolumab)+Yervoy (ipilimumab) regimen, an immunotherapy combination, to include clinical data from CheckMate -067, a trial in patients with previously untreated advanced melanoma. The FDA also granted priority review for this application with a target action date of January 23, 2016.

In the US, the FDA has approved Opdivo for treating 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.

Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 50 trials as a monotherapy or in combination with other therapies.

Source: Bristol-Myers Squibb

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