FDA Approves Subcutaneous Opdivo Qvantig for Multiple Solid Tumors
Key Insights
The FDA approved Opdivo Qvantig, a subcutaneous injection of nivolumab, for adult solid tumors previously approved for intravenous Opdivo.
CheckMate-67T trial data showed non-inferior pharmacokinetic exposures, similar efficacy, and comparable safety to intravenous Opdivo.
Opdivo Qvantig offers a faster 3-5 minute administration time, providing convenience and flexibility for patients.
The U.S. Food and Drug Administration (FDA) has granted approval to Bristol Myers Squibb (search)'s Opdivo Qvantig, a subcutaneous injection of nivolumab, for the treatment of most previously approved adult solid tumor (search) indications where intravenous Opdivo is indicated. This includes use as monotherapy, maintenance therapy following Opdivo plus Yervoy combination therapy, or in combination with chemotherapy or cabozantinib.
The approval is based on results from the Phase 3 CheckMate-67T trial, a randomized, open-label study that compared Opdivo Qvantig to intravenous Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma (search) who had received prior systemic therapy. The trial demonstrated non-inferior co-primary pharmacokinetic exposures, similar efficacy in overall response rate, and a comparable safety profile between the two formulations.
Clinical Trial Data
The CheckMate-67T trial's findings highlight the potential for Opdivo Qvantig to offer a more convenient administration route without compromising efficacy or safety. The trial met its primary endpoints, demonstrating that the subcutaneous formulation achieved comparable drug exposure and efficacy to the intravenous formulation. The safety profile was also consistent between the two routes of administration.
Enhanced Convenience and Patient Experience
Opdivo Qvantig offers a significant advantage in terms of administration time, reducing it from the 30-minute intravenous infusion to a 3-5 minute subcutaneous injection. According to medical oncologist Saby George, this quicker delivery may allow patients, in consultation with their doctors, to choose another treatment method and the flexibility to receive treatment closer to home.
Strategic Implications for Bristol Myers Squibb
This approval comes at a crucial time for Bristol Myers Squibb (search), as the company faces patent expirations for key drugs like Revlimid and Eliquis. Opdivo Qvantig, co-formulated with Halozyme Therapeutics' Enhanze drug delivery technology, could help the company maintain its market share in the face of increasing biosimilar competition. The list price of Opdivo Qvantig will be at parity with the intravenous version.
Adam Lenkowsky, Bristol Myers Squibb (search)’s chief commercialization officer, stated that the company looks forward to further helping cancer patients with an administration method that gives them faster delivery.