Nivolumab Assigned Priority Review for First-Line in Melanoma

Surabhi Dangi-Garimella, PhD

The PD-1 inhibitor nivolumab (Opdivo), developed by Bristol-Myers Squibb (BMS), has been assigned a priority review by the FDA for use in treatment-naïve patients with advanced melanoma. The drug first passed the FDA’s scrutiny in December 2014, becoming the second immuno-oncology agent from BMS to do so, when it was approved for patients with advanced melanoma who had progressed on ipilimumab (Yervoy) and a B-Raf inhibitor if they harbored the BRaf V600 mutation.1

To support the application, BMS has submitted phase 3 results from the CheckMate-066 trial, in which the performance of treatment-naïve, advanced melanoma patients (with wild type Braf) on nivolumab was compared with that of patients on dacarbazine chemotherapy. Treatment with nivolumab improved overall survival (OS) by 58% and progression free survival (PFS) by 57% compared with dacarbazine. There were indications of a biomarker-based response PD-L1–positive patients had a 70% improvement in OS, while the objective response rate was 52.7% with nivolumab versus 10.8% for dacarbazine.2 “The CheckMate-066 trial marked the first time that a PD-1 immune checkpoint inhibitor showed a survival benefit in a randomized phase 3 trial,” said Michael Giordano, BMS senior vice president and head of development, oncology .1

According to the company’s website, the FDA is required to act by August 27, 2015.
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