Dr Dronca on the FDA Approval of Subcutaneous Nivolumab in Solid Tumors

"Subcutaneous the approval of subcutaneous nivolumab really represents a shift, especially for solid tumors, in how cancer treatments are delivered and conceptualized. It really sets the stage, I think, for a broader acceptance of subcutaneous therapies in solid tumors."

Roxana S. Dronca, MD, hematologist, oncologist, chair, Department of Hematology/Oncology, Florida site deputy director, Mayo Clinic Comprehensive Cancer Center, discusses the clinical implications of the FDA approval of nivolumab and hyaluronidase-nvhy (Opdivo Qvantig; subcutaneous nivolumab) across solid tumor indications.

On December 27, 2024, the FDA approved subcutaneous nivolumabfor across approved adult solid tumor nivolumab (Opdivo) indications as monotherapy, monotherapy maintenance following completion of nivolumab plus ipilimumab (Yervoy) combination therapy, or in combination with chemotherapy or cabozantinib (Cabometyx).

The approval covers indications for adult patients with solid tumors such as renal cell carcinoma (RCC), melanoma, non–small cell lung cancer (NSCLC), head and neck squamous cell carcinoma, urothelial carcinoma, colorectal cancer, hepatocellular carcinoma, esophageal carcinoma, gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. However, subcutaneous nivolumab is not indicated in combination with intravenous (IV) ipilimumab.

This approval introduces an alternative delivery method for nivolumab, offering enhanced convenience without compromising efficacy, Dronca explains.

The regulatory decision was supported by data from the phase 3 CHECKMATE-67T trial (NCT04810078), which demonstrated pharmacokinetic noninferiority of the subcutaneous formulation compared with the IV formulation. Specifically, the geometric mean ratio (GMR) between the subcutaneous and IV formulations for serum nivolumab Cavg over 28 days and Cmin at steady state were 2.098 (90% CI, 2.001-2.200) and 1.774 (90% CI, 1.633-1.927), respectively, meeting the predefined study criteria. Additionally, patients with advanced or metastatic clear cell RCC treated with subcutaneous nivolumab achieved an overall response rate (ORR) of 24% (95% CI, 19%-30%) vs 18% (95% CI, 14%-24%) for those treated with IV nivolumab.

Dronca notes that this approval represents a paradigm shift in oncology care. Subcutaneous nivolumab simplifies treatment administration, significantly reducing the time patients need to spend in clinic. Traditional IV administration often requires prolonged infusion times, necessitating central venous access in some cases, which can impose significant physical and emotional burdens on patients, she continues. In contrast, subcutaneous administration requires only a brief injection, allowing patients to spend less time in treatment facilities.

Subcutaneous delivery also has broader implications for care accessibility, Dronca explains, offering clinicians the potential to administer these treatments in alternative health care settings, such as primary care offices or even at home, which could ultimately reduce disparities for patients in rural areas or those with limited access to tertiary cancer centers.

The approval of subcutaneous nivolumab highlights a growing emphasis on patient-centered care in oncology by improving convenience and accessibility without compromising clinical efficacy, Dronca concludes.