FDA approves subcutaneous nivolumab (Opdivo Qvantig) for cancer treatment, offering an alternative to intravenous infusion. This option is for adults with specific solid tumors, enhancing patient convenience. Subcutaneous administration showed non-inferior efficacy and safety compared to intravenous, with higher drug exposure.
FDA approved Opdivo for subcutaneous injection in adults with solid tumors, based on CHECKMATE-67T study showing similar safety and efficacy to intravenous form.
The FDA approved an injectable version of Bristol Myers Squibb’s cancer drug, Opdivo, enhancing patient convenience and potentially protecting sales as the intravenous version’s patent nears expiration.
The FDA approved subcutaneous nivolumab (Opdivo), the first subcutaneously administered PD-1 inhibitor, for all previously approved solid tumor indications. Supported by the CheckMate-67T study, it showed noninferior pharmacokinetics and response compared to IV formulation, with a 24.2% ORR.
FDA approved subcutaneous nivolumab for all solid tumor indications previously approved for nivolumab, supported by CheckMate-67T trial data showing noninferiority to intravenous administration.
Bristol Myers Squibb's Opdivo Qvantig, a subcutaneous injection for advanced or metastatic clear cell renal cell carcinoma, received FDA approval. The Phase 3 trial showed it's non-inferior to IV treatment, with similar efficacy and safety, offering faster administration and flexibility for patients.
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FDA approved Opdivo Qvantig for subcutaneous use in most solid tumor indications, offering faster administration and comparable efficacy to IV Opdivo, based on Phase 3 CheckMate-67T trial results.