FDA to Review Injectable Opdivo for All Approved Indications

A Biologics License Application for subcutaneous Opdivo was accepted by the FDA for patients with solid tumors.

The Food and Drug Administration (FDA) accepted a Biologics License Application (BLA) for subcutaneous Opdivo (nivolumab) across all indications for which the immunotherapy drug is approved to treat adults with solid tumors, according to Bristol Myers Squibb, the manufacturer of the drug.

Subcutaneous administration means that the drug will be injected under the skin. Currently, Opdivo is approved in an intravenous (IV) form, which involves administering the drug to a vein over a period of time.

The subcutaneous method can be done quicker compared with IV treatment, which typically takes 30 to 60 minutes.

READ MORE: Injectable Opdivo ‘Can Achieve the Same Goals’ as IV Use in RCC

In accepting the BLA, the FDA now agrees to review data on the safety and effectiveness of subcutaneous Opdivo. The agency plans to make their approval decision by Feb. 28, 2025, according to the Bristol Myers Squibb press release.

“We believe subcutaneous [Opdivo] has the potential to make a significant difference in the lives of patients, which is reinforced by the FDA’s acceptance of our application,” Gina Fusaro, vice president, global program lead, Bristol Myers Squibb, said in a press release. “If approved by the FDA, the subcutaneous administration of [Opdivo] would provide patients and their physicians with a new option that delivers the same well-known benefits as IV Opdivo but with the improved convenience of an injection administered in three-to-five minutes rather than a 30-to-60-minute infusion.”

Opdivo is currently FDA-approved, either alone or in combination with other therapies, for approximately two dozen indications, including metastatic melanoma, non-small cell lung cancer, renal cell carcinoma, head and neck cancer, bladder cancer, colorectal cancer and liver cancer.

The BLA is based on findings from the phase 3 CheckMate-67T trial, which compared subcutaneous versus IV Opdivo in patients with previously treated advanced or metastatic renal cell carcinoma (a type of kidney cancer). Data proved that subcutaneous Opdivo was not inferior to IV administration of the drug when it came to the average amount of Opdivo present in the blood serum over 28 days and the concentration of the drug in the blood before the next treatment.

Study findings also showed that subcutaneous Opdivo was not inferior to IV Opdivo in objective response rate (ORR) — a statistic that describes the percentage of patients whose disease shrinks or disappears from treatment, according to the National Cancer Institute. Specifically, data from CheckMate-67T that were presented at the American Society of Clinical Oncology 2024 Genitourinary Cancers Symposium found that the ORR was 24.2% in the subcutaneous group and 18.2% in the IV group.

Not only is subcutaneous administration of Opdivo quicker and more convenient, but it could also mitigate treatment disparities, according to Dr. Saby George, director of Network Clinical Trials and a professor of Oncology and Medicine at Roswell Park Comprehensive Cancer Center, as well as an associate professor at the Jacobs School of Medicine and Biomedical Sciences at the University of Buffalo. In a January 2024 interview with CURE®, George explained, “Intravenous [Opdivo] is given in infusion centers, while [subcutaneous] can be given in clinics. You don't need any big setup or any IV access or port or anything for subcutaneously administered drugs. That's making it attractive for patients. This also touches upon the access issue, especially [for] patients in remote areas, [who] find it difficult to come to infusion centers, [find a] ride etc.”

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