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In today’s episode, supported by Bristol Myers Squibb, we had the pleasure of speaking with Roxana S. Dronca, MD, about the FDA approval of subcutaneous nivolumab and hyaluronidase-nvhy (Opdivo Qvantig; subcutaneous nivolumab) for advanced or metastatic solid tumors. Dr Dronca is a professor of oncology, a consultant in the Division of Hematology/Oncology in the Department of Internal Medicine, and director of the Mayo Clinic Comprehensive Cancer Center in Jacksonville, Florida.

 across approved adult, solid tumor nivolumab indications, including as monotherapy, monotherapy maintenance after completion of nivolumab in combination with ipilimumab (Yervoy), or in combination with cabozantinib (Cabometyx) or chemotherapy. This regulatory decision was backed by findings from the phase 3 CheckMate-67T trial (NCT04810078) and includes indications for melanoma, renal cell carcinoma, non–small cell lung cancer, urothelial carcinoma, head and neck squamous cell carcinoma, colorectal cancer, esophageal carcinoma, esophageal adenocarcinoma, hepatocellular carcinoma, gastric cancer, and gastroesophageal junction cancer.

In our exclusive interview, Dr Dronca discussed the significance of this FDA approval across multiple solid tumor indications, pivotal findings from the CheckMate-67T trial, and how this approval represents a paradigm shift in modern cancer care delivery.

That’s all we have for today! Thank you for listening to this episode of 

, supported by Bristol Myers Squibb. Check back on Mondays and Thursdays for exclusive interviews with leading experts in the oncology field.

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Podcasts

Dr Dronca discusses the FDA approval of subcutaneous nivolumab and hyaluronidase for advanced or metastatic solid tumors. 

FDA Approval Insights: Subcutaneous Nivolumab for Advanced Solid Tumors: With Roxana S. Dronca, MD

Roxana S. Dronca, MD

"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.

for 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 C

 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.

Videos

Roxana S. Dronca, MD, discusses the FDA’s approval of subcutaneous nivolumab across solid tumor indications.

Roxana S. Dronca, MD

Articles

FDA Approval Insights: Subcutaneous Nivolumab for Advanced Solid Tumors: With Roxana S. Dronca, MD

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