Posted by Michael Wonder on 24 Jul 2017
U.S. FDA accepts Bristol-Myers Squibb’s applications for Opdivo (nivolumab) four-week dosing schedule across all approved indications
24 July 2017 - Bristol-Myers Squibb today announced that the U.S. FDA accepted its supplemental biologics license applications to update Opdivo (nivolumab) dosing to include 480 mg infused over 30 minutes every four weeks for all currently approved monotherapy indications.
“Filing for four week dosing infused over 30 minutes across approved Opdivo monotherapy indications supports our commitment to address cancer care from all angles. Driving innovation and making treatment more convenient for healthcare providers, caregivers and patients living with this disease is a priority for BMS,” said Murdo Gordon, executive vice president and chief commercial officer, Bristol-Myers Squibb.
The applications are under review with an action date of 5 March 2018.
