FDA accepts sBLA for new Opdivo dosing schedule

Bristol-Myers Squibb Co. (NYSE:BMY) said FDA accepted for review an sBLA to update the dosing for Opdivo nivolumab (BMS-936558, MDX-1106, ONO-4538) to include 480 mg infused over 30 minutes every 4 weeks for all currently approved monotherapy indications. The PDUFA date is March 5, 2018.

The current recommended dose of Opdivo monotherapy according to its FDA label is 240 mg infused over 60 minutes every 2 weeks...