FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injection

Regulatory approval: On Dec 27, 2024, the FDA approved nivolumab and hyaluronidase-nvhy (Opdivo Qvantig) for subcutaneous injection across approved adult solid-tumor nivolumab indications, as monotherapy, monotherapy maintenance after Opdivo plus Yervoy, or in combination with chemotherapy or cabozantinib. The approval was supported by CHECKMATE-67T in advanced/metastatic clear cell RCC, showing pharmacokinetic comparability to IV nivolumab and ORR 24% vs 18%.

FDA approval: nivolumab and hyaluronidase-nvhy for subcutaneous injection

Type: Regulatory approval
Agency: FDA
Date: 2024-12-27

On December 27, 2024, the FDA approved nivolumab and hyaluronidase-nvhy (Opdivo Qvantig; Bristol Myers Squibb) for subcutaneous injection across approved adult, solid-tumor nivolumab (Opdivo) indications. Use includes monotherapy, monotherapy maintenance following completion of Opdivo + Yervoy (ipilimumab), or in combination with chemotherapy or cabozantinib. The product is not indicated in combination with intravenous ipilimumab.

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 (see prescribing information for indication-specific details).

Supporting evidence (CHECKMATE-67T; NCT04810078)

CHECKMATE-67T was a multicenter, randomized, open-label trial in advanced/metastatic clear cell RCC with ≤2 prior systemic regimens (n=495), comparing subcutaneous nivolumab/hyaluronidase-nvhy vs intravenous nivolumab.

  • Primary objective: nivolumab exposure. The trial met the predefined pharmacokinetic acceptance margin (lower bound of 90% CI for geometric mean ratios ≥0.8 for Cavg over 28 days and Cmin at steady state).
  • Key secondary objective: ORR by blinded independent central review: 24% (95% CI 19–30) subcutaneous vs 18% (95% CI 14–24) intravenous.
  • Safety: generally similar between arms; most common adverse reactions (≥10%) were fatigue, musculoskeletal pain, pruritus, rash, and cough.

Dosing (per label)

Recommended regimens include 600 mg/10,000 units q2w, 900 mg/15,000 units q3w, or 1,200 mg/20,000 units q4w, until progression, unacceptable toxicity, or as specified.

The review was conducted under Project Orbis; reviews were ongoing at collaborating agencies.

Sources