Supplemental BLAs accepted by FDA for new four-week dosing schedule of Opdivo® (nivolumab)

On 24th July 2017, the U.S. Food and Drug Administration (FDA) accepted the Supplemental Biologics License Applications (sBLAs) submitted by Bristol-Myers Squibb to update the dosing of Opdivo® (nivolumab).

The proposed update to the dosing is 480mg infusion over 30 minutes every four weeks for all currently approved monotherapy indications, which includes the treatment of adult patients with Classical Hodgkin lymphoma (cHL) who have experienced relapse or progressed after Autologous Hematopoietic Stem Cell Transplantation (ASCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that included ASCT.

Currently, the recommended dosing of nivolumab is 3mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.

Nivolumab is a fully humanized IgG4 monoclonal antibody that targets Programmed Death-1 (PD-1) and prevents its activation by its ligands Programmed Death Ligand 1 and 2 (PD-L1/PD-L2). Opdivo® was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014.

The sBLAs are under review with an action date of 5th March 2018.


1. Street Insider. Bristol-Myers Squibb (BMY) Says FDA Accepts Applications for Opdivo Four-Week Dosing Schedule Across All Approved Indications. 2017 Jul 24. https://www.streetinsider.com/Corporate+News/Bristol-Myers+Squibb+%28BMY%29+Says+FDA+Accepts+Applications+for+Opdivo+Four-Week+Dosing+Schedule+Across+All+Approved+Indications/13123314.html. [Accessed 2017 Jul 25].