Officials with the FDA have approved nivolumab and hyaluronidase-nvhy (Opdivo Qvantig; Bristol Myers Squibb) for subcutaneous injection across approved adult, solid tumor nivolumab indications as monotherapy, monotherapy maintenance following completion of combination therapy.1
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. The approval was based on data from CheckMate 67T (NCT04810078), a multicenter, open-label trial in patients with advanced or metastatic clear cell renal cell carcinoma who were randomly assigned to receive either subcutaneous nivolumab and hyaluronidase-nvhy or intravenous nivolumab.
The trial met the predefined acceptance margin for pharmacokinetic end points, with the lower boundary of 90% confidence interval (CI) of geometric mean ratios of not less than 0.8 for both serum nivolumab Cavg over 28 days and Cmin at steady state. Overall response rate was 24% (95% CI, 19-30) in the subcutaneous nivolumab and hyaluronidase-nvhy arm and 18% (95% CI, 14-24) in the intravenous nivolumab arm.
The most common adverse reactions noted in the trial (≥10%) were fatigue, musculoskeletal pain, pruritus, rash, and cough.
The recommended dosage depends on the specific indication and is either 600 mg nivolumab and 10,000 units hyaluronidase every 2 weeks; 900 mg nivolumab and 15,000 units hyaluronidase every 3 weeks; or 1200 mg nivolumab and 20,000 units hyaluronidase every 4 weeks until disease progression, unacceptable toxicity, or as indicated in the prescribing information.
Reference
- FDA. FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injection. December 27, 2024. Accessed February 5, 2025. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-and-hyaluronidase-nvhy-subcutaneous-injection