The US Food and Drug Administration (FDA) has extended the action date for Bristol-Myers Squibb’s supplemental biologics license application (sBLA) for Opdivo for treating previously untreated advanced melanoma. The company has taken the opportunity to submit additional data from the Opdivo clinical trial program to ensure the broadest data set, irrespective of BRAF status, was available for review. This submission constitutes a major amendment that will require additional time for review and the new FDA action date is November 27, 2015.

The sBLA was accepted by the FDA for filing and received priority review designation on April 29, 2015, and included data from a Phase III that evaluated Opdivo in treatment-naïve patients with BRAF wild-type advanced melanoma as compared to dacarbazine chemotherapy. The company will continue to work closely with the agency to support the review of this sBLA for Opdivo.

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that has received approval from the FDA as a monotherapy in two cancer indications. On March 4, 2015, Opdivo received FDA approval for treating metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy. In the US, Opdivo is also indicated 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. 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 in which more than 8,000 patients have been enrolled worldwide.

Source: Bristol-Myers Squibb