FDA Accepts sBLAs for 4-week Nivolumab Dosing Schedule

July 25, 2017 – The FDA has accepted a supplemental Biologics License Applications (sBLAs) seeking to add a second dosing schedule for nivolumab across all of the PD-1 inhibitor’s monotherapy indications, according to Bristol-Myers Squibb (BMS). If approved, doctors would be able to prescribe the new dosing schedule of 480 mg of nivolumab every 4 weeks. Nivolumab is currently approved as a single-agent for: Advanced melanoma 240 mg IV infused over … (leggi tutto)