Bristol Myers Squibb (BMS) has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new Opdivo® (nivolumab) formulation associated with a different route of administration (subcutaneous use), an alternative pharmaceutical form (solution for injection) and a new strength (600 mg/vial).
Nivolumab for subcutaneous use is co-formulated with recombinant human hyaluronidase (rHuPH20) and is indicated across multiple adult solid tumours, approved prior to 2025, for administration every two or four weeks:
• as monotherapy1,2
• as monotherapy maintenance following completion of nivolumab plus ipilimumab combination therapy1,2
• in combination with chemotherapy or cabozantinib1,2
Subcutaneous nivolumab will be provided by the National Health Service (NHS) England.
Rob Duncombe, Chief Pharmacist at The Royal Marsden NHS Foundation Trust, said: “The approval of subcutaneous nivolumab offers eligible patients a new way to receive this drug that may provide greater flexibility while delivering the same efficacy as achieved with IV nivolumab.
“The administration time for the subcutaneous dose is three to five minutes compared to the current 30 to 60 minutes associated with the IV administration route. Subcutaneous nivolumab may reduce chair time for patients and increase the options as to where they can receive their treatment, allowing for an overall more convenient treatment experience.”
Subcutaneous administration may offer flexibility to receive treatment where it is best-suited for patients and their healthcare providers and may reduce time needed for administration.4,5,6,7,8,9 In the CheckMate-67T trial, administration time with the subcutaneous formulation of nivolumab was on average less than five minutes, and most patients received all doses of the study medication without an injection interruption or dose delay.10 Over the course of several cycles of treatment, administered every two or four weeks, the reduction in administration time from 30-60 minutes to 3-5 minutes has the potential to save time for the healthcare provider and free up resources for the health system.
The approval is based on results from the CheckMate-67T trial, in which subcutaneous nivolumab demonstrated noninferiority of Cavgd28 (time-averaged nivolumab serum concentration over 28 days) and Cminss (minimum steady state serum concentration), the study’s primary endpoints, vs. IV nivolumab in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received no more than two prior lines of systemic therapy.2,10 The Geometric mean ratio (GMR) for Cavgd28 was 2.10 (90% CI:2.00-2.20) and the GMR for Cminss was 1.77 (90% CI: 1.63-1.93).10 Additionally, as a key powered secondary endpoint, the objective response rate in the subcutaneous nivolumab arm (n=248) was 24% (95% CI: 19-30), compared with 18% (95% CI: 14-24) in the IV nivolumab arm (n=247), showing that subcutaneous nivolumab has similar efficacy compared to IV nivolumab.2,10 The safety profile of subcutaneous nivolumab was consistent with the IV formulation.2,10 The pharmacokinetics, efficacy and safety results from CheckMate-67T were presented at the 2024 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium11 and the European Society for Medical Oncology (ESMO) Congress.12
References:
1 Medicines and Healthcare products Regulatory Agency. OPDIVO 600 mg solution for injection.
2 Medicines and Healthcare products Regulatory Agency. OPDIVO 600 mg solution for injection.
3 Data on file.
4 De Cock E, Kritikou P, Sandoval M, et al. Time Savings with Rituximab Subcutaneous Injection versus Rituximab Intravenous Infusion: A Time and Motion Study in Eight Countries. PLoS One. 2016;11(6):e0157957.
5 Lopez-Vivanco G, Salvador J, et al. Cost minimization analysis of treatment with intravenous or subcutaneous trastuzumab in patients with HER2-positive breast cancer in Spain. Clin Transl Oncol. 2017;19(12):1453-1461.
6 Dent S, Ammendolea C, Christofides A, et al. A multidisciplinary perspective on the subcutaneous administration of trastuzumab in HER2-positive breast cancer. Curr Oncol. 2019;26(1):e70-e80.
7 McCloskey C, Ortega MT, Nair S, et al. A Systematic Review of Time and Resource Use Costs of Subcutaneous Versus Intravenous Administration of Oncology Biologics in a Hospital Setting. Pharmacoecon Open. 2023;(7)1:3-36.Page 4/4 © 2025 Bristol-Myers Squibb Company | May 2025 | 1506-GB-2500109
8 Bittner B, Schmidt J. Advancing Subcutaneous Dosing Regimens for Biotherapeutics: Clinical Strategies for Expedited Market Access. BioDrugs. 2024:38(1):23-46.
9 Burcombe R, Chan S, et al. Subcutaneous Trastuzumab (Herceptin®): A UK Time and Motion Study in Comparison with Intravenous Formulation for the Treatment of Patients with HER2-Positive Early Breast Cancer. Advances in Breast Cancer Research. 2012;2(4).
10 Albiges L, Bourlon MT, Chacón M, et al. Subcutaneous versus intravenous nivolumab for renal cell carcinoma. Ann Oncol. 2024:S0923-7534(24)03996-6.
11 George S, et al. Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): Pharmacokinetics (PK), efficacy, and safety results from CheckMate 67T. 2024 ASCO Genitourinary Cancers Symposium. Journal of Clinical Oncology. 2024:42(4).
12 Albiges L, et al. 1691P – Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients (pts) with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): Updated efficacy and safety results from CheckMate 67T. ESMO 2024. Available at: https://oncologypro.esmo.org/meeting-resources/esmo-congress-2024/subcutaneous-nivolumab-nivo-sc-vs-intravenous-nivolumab-nivo-iv-in-patients-pts-with-previously-treated-advanced-or-metastatic-clear-cell-ren. Accessed: April 2025.
May 2025 | 1506-GB-2500109
