Bristol-Myers Squibb reports 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 with advanced renal cell carcinoma (RCC) after prior therapy. Validation of the application confirms the submission is complete and begins the EMA's centralized review process.

The Type II variation submitted is based on data from a Phase III clinical study that evaluated, as the primary endpoint, the overall survival of Opdivo versus everolimus, a current standard of care, in advanced or metastatic clear-cell RCC after prior anti-angiogenic treatment.

The US Food and Drug Administration has granted Breakthrough Therapy Designation to Opdivo for RCC. The Breakthrough Therapy designation is an FDA program intended to expedite the development and review of medicines with early signals of potential clinical benefit in serious diseases to help ensure patients have access to new therapies as soon as possible.>/p>

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