FDA

SC formulation of nivolumab approved

January 7, 2025

Brand name: Opdivo Qvantig

Generic name: nivolumab and hyaluronidase-nvhy

Manufacturer: Bristol Myers Squibb

Approval date: December 27, 2024

FDA approved Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) for SC injection across approved adult, solid tumor nivolumab (Opdivo) indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.

Approved indications include 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.

Note: Opdivo Qvantig is not indicated in combination with IV ipilimumab.

Efficacy

The SC injection of nivolumab and hyaluronidase-nvhy was evaluated in the multicenter, randomized, open-label CHECKMATE-67T trial (NCT04810078) involving patients with advanced or metastatic clear cell renal cell carcinoma who received no more than 2 prior systemic treatment regimens. A total of 495 patients were randomized to receive either SC nivolumab and hyaluronidase-nvhy or IV nivolumab.

The primary objective was to assess nivolumab exposure of SC administration of Opdivo Qvantig vs. IV nivolumab. The key secondary objective was to evaluate overall response rate (ORR), assessed by blinded independent central review. The trial met the predefined acceptance margin for pharmacokinetic endpoints, with the lower boundary of 90% confidence interval of geometric mean ratios of not less than 0.8 for both serum nivolumab Cavg over 28 days and Cmin at steady state. ORR was 24% (95% CI, 19-30) in the SC nivolumab and hyaluronidase-nvhy arm and 18% (95% CI, 14-24) in the IV nivolumab arm.

Safety

In general, CHECKMATE-67T showed a similar safety profile between Opdivo Qvantig and IV nivolumab. The most common adverse reactions (≥10%) were fatigue, musculoskeletal pain, pruritus, rash, and cough.

Recommended dose

The recommended dosage depends on the specific indication and is either of the following doses until disease progression, unacceptable toxicity, or as indicated in the prescribing information:

• 600 mg nivolumab and 10,000 units hyaluronidase q2wks
• 900 mg nivolumab and 15,000 units of hyaluronidase q3wks
• 1,200 mg nivolumab and 20,000 units hyaluronidase q4wks

Sources:

FDA. (2024, December 17). FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injection. [Press release]. https://www.empr.com/news/fda-approves-opdivo-qvantig-a-subcutaneous-formulation-of-nivolumab/

Bristol Myers Squibb. (2024, December 27). U.S. Food and Drug Administration Approves Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) Injection, for Subcutaneous Use in Most Previously Approved Adult, Solid Tumor Opdivo (nivolumab) Indications. [Press release]. https://news.bms.com/news/corporate-financial/2024/US-Food-and-Drug-Administration-Approves-Opdivo-Qvantig-nivolumab-and-hyaluronidase-nvhy-Injection-for-Subcutaneous-Use-in-Most-Previously-Approved-Adult-Solid-Tumor-Opdivo-nivolumab-Indications12/default.aspx

Bristol Myers Squibb: Opdivo Qvantig (nivolumab and hyaluronidase-nvhy). [Package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761429s000lbl.pdf