FDA Approves Subcutaneous Opdivo to Treat Solid Tumors

The FDA granted approval for Opdivo Qvantig (nivolumab and hyaluronidase-nvhy), a subcutaneous version of Opdivo, to treat patients with solid tumors. It is approved as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.

“Opdivo Qvantig offers faster administration, delivered in three to five minutes. It may allow patients, in consultation with their doctors, to choose another treatment method and the flexibility to receive treatment closer to home,” Professor Saby George, M.D., FACP, medical oncologist and director of network clinical trials at Roswell Park Comprehensive Cancer Center, said in a news release.

Opdivo Qvantig was not approved for several indications, including in combination with Yervoy to treat patients with renal cell carcinoma, metastatic melanoma, metastatic non-small cell lung cancer and metastatic esophageal cancer.

Developed by Bristol Myers Squibb, Opdivo Qvantig is expected to be available to patients in early January 2025. It will be priced at parity to the intravenous version of Opdivo, according to a company spokesperson. Opdivo injection 240 mg every two weeks has a list price of $7,635 per infusion; Opdivo injection 480 mg given every four week has a list price of $15,269.

“We take great care to price our medicines based on the value they deliver, the scientific innovation they represent, economic factors that impact a healthcare system’s capacity to provide appropriate, rapid and sustainable access to patients, and the investment necessary to develop these medicines,” the spokesperson said. “As the first and only subcutaneously administered PD-1 inhibitor, the cost of Opdivo Qvantig is reflective of the clinical value it brings.”

Bristol Myers Squibb is meeting with payers to help provide access to patients. The BMS Access Support program provides resources, including $0 copay assistance for eligible commercially insured patients. 

The approval of Opdivo Qvantig is based on the results from the phase 3 CheckMate-67T trial, which demonstrated non-inferior co-primary pharmacokinetic (PK) exposures, similar efficacy in overall response rate (ORR), and showed a comparable safety profile compared with intravenous Opdivo. In the CM–67T trial, average administration time with Opdivo Qvantig was approximately five minutes, and most patients received all doses of the study medication without an injection interruption or dose delay. The IV form of Opdivo is infused over a 30-minute period.

Serious adverse reactions occurred in 28% of patients receiving Opdivo Qvantig. The most frequent serious adverse reactions reported in were pleural effusion (fluid build up), pneumonitis, hyperglycemia, hyperkalemia, hemorrhage and diarrhea.

Opdivo Qvantig also has the same warnings as Opdivo on the risk of severe and fatal immune-mediated adverse reactions including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, nephritis with renal dysfunction, dermatologic adverse reactions, other immune-mediated adverse reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo-fetal toxicity; and increased mortality in patients with multiple myeloma.