BRIEF—Opdivo first FDA-approved PD-1 inhibitor to offer every four-week dosing

The US Food and Drug Administration has approved Bristol-Myers Squibb’s supplemental Biologics License Application (sBLA) updating the Opdivo (nivolumab) dosing schedule to include 480mg infused every four weeks (Q4W) for a majority of approved indications in the treatment of various cancers.

This approval will provide health care professionals the flexibility to customize patient care with the option of using the newly approved Q4W (480mg) flat dose in addition to the previously available option of every two weeks (Q2W) at 240mg, now available in a new 240mg vial.

Opdivo was also approved for a shorter 30-minute infusion across all approved indications.

Dosing schedule updates for an additional approvedindication for Opdivo may be submitted to the FDA in the future, said B-MS.