FDA accepts Bristol-Myers’ sBLA for melanoma drug Opdivo

Opdivo is a programed death-1 (PD-1) immune checkpoint inhibitor that has received approval from the FDA as a monotherapy in two cancer indications.

The sBLA is based on data from CheckMate -066, which evaluated Opdivo in treatment naïve patients with BRAF wild-type advanced melanoma as compared to dacarbazine chemotherapy (DTIC).

During the trial, safety and tolerability were well-characterized with fewer treatment-related Grade 3/4 adverse events observed with Opdivo than dacarbazine.

Bristol-Myers Squibb senior vice-president and head of Development, Oncology Michael Giordano said: "The CheckMate -066 trial marked the first time that a PD-1 immune checkpoint inhibitor showed a survival benefit in a randomized Phase III trial.

"We look forward to continuing to work with the FDA to ensure cancer patients are provided the latest clinical advances that have the potential for improved responses and long-term survival."

The agency has also granted priority review for this application and the projected FDA action date is 27 August 2015.

In December 2014, Opdivo was first approved by the FDA for patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor.

This initial indication was approved under accelerated approval based on tumor response rate and durability of response from CheckMate -037 clinical trial results.

In March this year, Opdivo was approved by the FDA to treat patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.