FDA Approves New Dosing Schedule for Cancer Therapy

03/06/18

The US Food and Drug Administration (FDA) has approved a 4-week dosing schedule for a commonly used cancer therapy.

Nivolumab (Opdivo, Bristol-Myers Squibb) is approved to treat a variety of cancers, including metastatic melanoma, metastatic non-small cell lung cancer, advanced renal cell carcinoma, and hepatocellular carcinoma, among others. The PD-1 inhibitor was previously approved for a dosing schedule of every 2 weeks, along with a shorter 30-minute infusion.

The latest FDA approval makes nivolumab the only PD-1 inhibitor available in a 4-week dosing schedule.

“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,” said Johanna Mercier, head, US Commercial, Bristol-Myers Squibb, in a press release (March 6, 2018). “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.”

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Nivolumab is associated with pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, and renal dysfunction.—Zachary Bessette