Regulatory Affairs

Bristol-Myers secures FDA approval for new dosing of cancer drug Opdivo

PBR Staff Writer Published 07 March 2018

The US Food and Drug Administration (FDA) has approved a four-week dosing schedule for Bristol-Myers Squibb's Opdivo cancer drug.

The regulator approved Opdivo label update offering flexible flat-dosing options every two weeks (240 mg) or every four weeks (480 mg).

Opdivo, which is a programmed death-1 (PD-1) inhibitor, was previously approved as a two-week dosing schedule for dosage strength of 240mg for the treatment of various cancers including melanoma, non–small cell lung cancer, and renal cell carcinoma.

The FDA has also approved Opdivo for a shorter 30-minute infusion for all its approved indications.

Opdivo’s approvals in the past have been as a single agent and also in combination with other drugs.

Bristol-Myers Squibb said that it may submit dosing schedule updates for an additional approved indication to the regulator in the future.

Bristol-Myers Squibb US Commercial head Johanna Mercier said: “At Bristol-Myers Squibb, we are united in our mission to fight cancer from all angles and recognize every patient has unique needs.

“From the introduction of our first Immuno-Oncology agent through today’s approval of flexible dosing options at two- or four-week intervals, we are relentless in pursuing innovative options for the cancer community.

“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.”

Opdivo functions by targeting the cellular pathway PD-1/PD-L1 proteins found on the body's immune cells and various cancer cells. By blocking the pathway, Opdivo helps the body's immune system fight cancer cells by restoring an anti-tumor immune response.

Last month, Bristol-Myers Squibb announced that Opdivo in combination with Yervoy (ipilimumab) significantly improved progression-free survival in non-small cell lung cancer (NSCLC) patients with high tumor mutation burden (TMB) in a first line setting in the CheckMate -227 phase 3 trial.

Image: BMS facility in Nassau Park, New Jersey, US. Photo: courtesy of Bristol-Myers Squibb Company.