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FDA Approves 4-Week Nivolumab Dosing Schedule

Jason M. Broderick @jasoncology
Published: Tuesday, Mar 06, 2018

Jeffrey Weber, MD, PhD

Jeffrey Weber, MD, PhD
The FDA has approved a supplemental biologics license application adding a 4-week dosing schedule for nivolumab (Opdivo) across several of the PD-1 inhibitor’s indications.

“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,” added Mercier.
A model-based exposure-response (E-R) assessment of a nivolumab (NIVO) 4-weekly (Q4W) dosing schedule across multiple tumor types [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; 2017 Apr 1-5; Washington, DC. Philadelphia (PA): AACR; Cancer Res 2017;77(13 Suppl):Abstract CT101. doi:10.1158/1538-7445.AM2017-CT101.

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