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FDA approves sBLA for new four-week dosing schedule of Opdivo® (nivolumab)

It was announced in a press release that the US Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for a four-week dosing schedule of Opdivo® (nivolumab) on 6 March 2018. This follows a license application that was submitted in July 2017

Previously, the recommended dosing of nivolumab was 3mg/kg administered as an intravenous infusion over 60 minutes every two weeks until disease progression or unacceptable toxicity. The approval will update the dosing schedule so that physicians have the option of giving patients 480mg infused every four weeks. This new dosing schedule has been approved for relapsed/refractory classical Hodgkin lymphoma after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or three or more lines of therapy that includes HSCT.

Johanna Mercier, head of U.S. Commercial at Bristol-Myers Squibb stated in the press release that, “with this approval, we now offer the most robust range of dosing options for an Immuno-Oncology medicine, providing enhanced flexibility to help address each patient’s specific needs.”

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.

References
  1. Business Wire. Bristol-Myers Squibb’s Opdivo® (nivolumab) Now the First and Only FDA-Approved PD-1 Inhibitor to Offer Every Four-Week Dosing. 2018 Mar 06. https://www.businesswire.com/news/home/20180306005877/en. [Accessed 2018 Mar 07]