FDA accepts filing of Opdivo (nivolumab) to treat non-squamous non-small cell lung cancer- BMS

BMS announced that the FDA has accepted for filing and review the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) for the treatment of previously treated patients with non-squamous non-small cell lung cancer (NSCLC). This sBLA seeks to expand the current indication for nivolumab in patients with previously treated squamous NSCLC. The projected FDA action date is 2 January 2016. The agency has also granted this application priority review and Breakthrough Therapy designation for this indication, underscoring the need for new treatments for this patient population, where currently a significant unmet medical need remains.

The EMA has already validated nivolumab as monotherapy for a variation application to extend the current indication for non squamous lung cancer. The type II variation submitted to the EMA in non-squamous NSCLC is supported by data from the landmark global Phase III study, CheckMate-057, which evaluated the survival of patients with advanced non-squamous NSCLC who had progressed during or after one prior platinum doublet-based chemotherapy regimen.