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FDA Approves New Administration Method for Opdivo (nivolumab)

January 6, 2025

On December 27, 2024, the U.S. Food and Drug Administration (FDA) approved Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) for subcutaneous injection, commonly known as a shot. This approval included all the same uses of Opdivo (nivolumab) that the FDA previously approved for adults, including for use as a standalone therapy or in combination with other treatments for non-small cell lung cancer (NSCLC). This latest approval is based on the results of the CHECKMATE-67T study, which compared the use of Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) given by a shot (injection) under the skin in the thigh versus traditional Opdivo (nivolumab) which is given as an infusion into the bloodstream (intravenous/IV). People given Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) as a shot received the drug over approximately 5 minutes compared to the standard 30 minutes by IV.  The study showed no difference in the drug’s safety profile between the 2 administration methods, and people given subcutaneous Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) had a slightly improved response rate. Opdivo (nivolumab) is a medication previously approved for use in adults for several indications, including NSCLC. Adding Hybreza (hyaluronidase-nvhy) to the shot helps improve the absorption and dispersion of Opdivo (nivolumab) within the body. Please speak with your healthcare team for more information about Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) to see if it may be a good option for you. If you have questions about treatment, trials, or biomarker testing, contact our LungMATCH team at support@go2.org or 1-800-298-2436.  Read the full FDA announcement.

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Lung cancer questions? Contact our free HelpLine at support@go2.org or 1-800-298-2436.