FDA Accepts sBLA for BMS’ Opdivo for RCC
The US Food and Drug Administration (FDA) has accepted for filing and priority review a supplemental biologics license application (sBLA) for Opdivo (nivolumab) for treating patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. The FDA previously granted Opdivo breakthrough therapy designation for this indication. The projected FDA action date is March 16, 2016.
Bristol-Myers Squibb reported earlier this month that the European Medicines Agency (EMA) validated a Type II variation application, which seeks to extend the current indication for Opdivo (nivolumab) to include the treatment of adult patients RCC after prior therapy. Validation of the application confirms the submission is complete and begins the EMA's centralized review process.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that has received FDA approval as a monotherapy in two cancer indications: for patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor, and for treating metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy. In July 2015, the European Commission approved Nivolumab BMS for treating locally advanced or metastatic squamous non-small cell lung cancer after prior chemotherapy. 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