FDA OKs Subcutaneous Nivolumab in Advanced/Metastatic Solid Tumors

The FDA approved Opdivo Qvantig, the subcutaneous formulation of nivolumab.

The FDA granted approval to nivolumab and hyaluronidase-nvhy (Opdivo Qvantig; subcutaneous nivolumab) 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 includes indications for renal cell carcinoma, melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, urothelial carcinoma, colorectal cancer, hepatocellular carcinoma, esophageal carcinoma, gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. Opdivo Qvantig is not indicated in combination with intravenous ipilimumab.

The regulatory decision was supported by data from the phase 3 CHECKMATE-67T trial (NCT04810078), which showed that the lower boundary of 90% confidence interval of geometric mean ratios was not less than 0.8 for both serum nivolumab C_avg over 28 days and C_min at steady state.

Patients with advanced or metastatic clear cell RCC treated with subcutaneous nivolumab experienced an overall response rate of 24% (95% CI, 19%-30%) compared with 18% (95% CI, 14%-24%) for those treated with intravenous nivolumab.

The safety profiles were similar for subcutaneous and intravenous nivolumab. In the subcutaneous arm, the most common adverse effects reported in at least 10% of patients included fatigue, musculoskeletal pain, pruritus, rash, and cough.

Reference

FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injection. FDA. December 27, 2024. Accessed December 27, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-and-hyaluronidase-nvhy-subcutaneous-injection