Posted by Michael Wonder on 06 Mar 2018
Bristol-Myers Squibb’s Opdivo (nivolumab) now the first and only FDA approved PD-1 inhibitor to offer every four week dosing
6 March 2018 - Opdivo also now approved for shorter 30-minute infusions, cutting previous infusion time in half
Bristol-Myers Squibb today announced the U.S. FDA has approved a supplemental biologics license application updating the Opdivo (nivolumab) dosing schedule to include 480 mg infused every four weeks (Q4W) for a majority of approved indications. This approval will provide health care professionals the flexibility to customise patient care with the option of using the newly approved Q4W (480 mg) flat dose in addition to the previously available option of every two weeks (Q2W) at 240 mg, now available in a new 240 mg vial.
Opdivo also was approved for a shorter 30 minute infusion across all approved indications. Dosing schedule updates for an additional approved indication for Opdivo may be submitted to the FDA in the future.
