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FDA Delays Review of Melanoma Drug Nivolumab (Opdivo)

Approval decision set for November

The FDA has extended the action date for the supplemental biologics license application (sBLA) for nivolumab (Opdivo) for the treatment of patients with previously untreated advanced melanoma.

The drug’s developer, Bristol-Myers Squibb, has submitted additional data from the nivolumab clinical trial program, and this action constitutes a major amendment that will require additional time for review. The new FDA action date is November 27, 2015.

The sBLA was accepted for filing and received a “priority review” designation in April 2015. The sBLA included data from the phase III CheckMate-066 trial, which compared nivolumab with dacarbazine chemotherapy (DTIC) in treatment-naïve patients with BRAF wild-type advanced melanoma.

Nivolumab is a programmed death-1 (PD-1) immune checkpoint inhibitor that has received FDA approval as monotherapy for two cancer indications. In March 2015, nivolumab was approved for the treatment of patients with metastatic squamous non–small-cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. The drug is also indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression after treatment with ipilimumab (Yervoy, Bristol-Myers Squibb) and, if BRAF V600 mutation-positive, a BRAF inhibitor.

Nivolumab became the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014 when Ono Pharmaceutical Co. announced that it had received manufacturing and marketing approval in Japan for the treatment of patients with unresectable melanoma.

Source: Bristol-Myers Squibb; August 12, 2015.

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