Subcutaneous Nivolumab Receives FDA Approval – A New Era in Cancer Treatment

On 27 December 2024, the US Food and Drug Administration (FDA) approved nivolumab and hyaluronidase-nvhy (Opdivo Qvantig, Bristol Myers Squibb) as a subcutaneous injection. This approval offers broad use while improving patient comfort and maintaining the efficacy and safety profile. The subcutaneous formulation may reduce the challenges of intravenous administration and provide flexibility in clinical use.

Which Cancers Will It Be Used For?

The FDA approved the new subcutaneous formulation for the following indications in which nivolumab (Opdivo) is used as monotherapy or in certain combination regimens:

• Renal cell carcinoma (kidney cancer)
• Melanoma
• Non-small cell lung cancer
• Head and neck squamous cell carcinoma
• Urothelial carcinoma (urinary tract cancer)
• Colorectal cancer
• Hepatocellular carcinoma (liver cancer)
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal cancer

However, this formulation is not suitable for use with intravenous ipilimumab (Yervoy).

The CHECKMATE-67T Study Behind the New FDA Approval

The efficacy and safety of subcutaneous injection were evaluated in patients with advanced or metastatic renal cell carcinoma in the CHECKMATE-67T study. The study compared subcutaneous nivolumab and hyaluronidase-nvhy with intravenous nivolumab in 495 patients.

• Pharmacokinetic Findings: Subcutaneous Opdivo Qvantig was equivalent to the intravenous formulation in pharmacokinetic parameters. In particular, serum Cavg over 28 days and steady-state Cmin were within acceptable limits (lower bound of the 90% confidence interval ≥0.8).

• Treatment Response (ORR): In the subcutaneous group, the overall response rate (ORR) was 24% (95% CI: 19, 30), compared with 18% (95% CI: 14, 24) in the intravenous group. These results show that the subcutaneous formulation is an effective alternative.

• Safety Profile: The two groups showed similar safety profiles. The most commonly reported adverse effects (more than 10%) were:

  • Fatigue
  • Musculoskeletal pain
  • Itching
  • Rash
  • Cough

Dosage and Administration

The dose of subcutaneous nivolumab and hyaluronidase-nvhy varies according to the disease type and treatment regimen:

• 600 mg nivolumab + 10,000 units hyaluronidase: Every 2 weeks
• 900 mg nivolumab + 15,000 units hyaluronidase: Every 3 weeks
• 1,200 mg nivolumab + 20,000 units hyaluronidase: Every 4 weeks

Treatment continues until disease progression or intolerable adverse effects.

Conclusion

This FDA approval offers a new treatment option for patients and clinicians by making immunotherapy easier to administer. In particular, the subcutaneous formulation improves patient comfort and stands out as a strong alternative to intravenous treatment through pharmacokinetic equivalence and an acceptable safety profile. This development represents an important step toward a patient-centered approach to cancer treatment.