The U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) updating the nivolumab dosing schedule to include 480 mg infused every 4 weeks for a majority of approved indications.
This approval will provide health-care professionals the flexibility to customize patient care with the option of using the newly approved every-4-week (480-mg) flat dose in addition to the previously available option of every 2 weeks at 240 mg, now available in a new 240-mg vial.
Nivolumab was also approved for a shorter 30-minute infusion across all approved indications.
Dosing schedule updates for an additional approved indication for nivolumab may be submitted to the FDA in the future.
The every-4-week (480-mg) flat-dose option is approved for the following indications for nivolumab:
“We continuously learn new ways to individualize treatment with immuno-oncology therapies, and in my experience, what works for one patient may not be optimal for another,”said Jeffrey S. Weber, MD, PhD, Deputy Director of the Perlmutter Cancer Center at NYU Langone Health and Professor of Medicine at NYU School of Medicine, New York. “For instance, some patients may need the support of 2-week visits with their health-care team, while for others, a 4-week interval may be more appropriate and better suited to their treatment needs. With this approval, we now have additional ways to help tailor patient care.”