Written by Priyanka Khamkar (M. Pharm) Pharmacology and Vikas Londhe M.Pharm, Pharmacology
The UK’s National Health Service (NHS) has rolled out Opdivo, an immunotherapy drug in a 3-5 minute injectable form, effective in 15 types of cancers. Opdivo is nivolumab, a monoclonal antibody that attaches to T-cells’ PD-1 (programmed death-1). The jab can be used to treat 15 different types of cancer, such as melanoma, esophageal, bladder, and skin cancer. The approval history of Nivolumab dates back to 2014, when it was first approved by the USFDA, followed by the EMA in 2015 for unresectable or metastatic melanoma. Since then, to date, nivolumab has been approved for a dozen cancer treatments, up to 15 cancers, by the FDA, EMA, and MHRA. Nivolumab was first developed by Medarex Inc., which was later acquired by Bristol Myers Squibb (BMS). BMS is now the marketing authorization holder of Opdivo in the EU and the MHRA. Nivolumab was earlier administered intravenously over a 30- to 60-minute IV drip, depending on the regimen and for which cancer it was being administered.
Bristol Myers-Squibb’s injectable form of nivolumab (Opdivo) is now available through NHS England, the first national health agency in Europe to do so. It allows treatment to be given in five minutes via the subcutaneous route as opposed to up to a one-hour administration via IV drip earlier. The announcement comes after approval from the Medicines and Healthcare Products Regulatory Agency (MHRA).
Opdivo (Nivolumab)
Opdivo has been approved for numerous cancers, including melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma, colorectal cancer, liver cancer, esophageal squamous cell carcinoma, gastric cancer, and gastroesophageal junction cancer.
Before the latest injectable form, Opdivo was administered as an intravenous infusion (IV drip) over 30 minutes every two to four weeks, depending on the type of cancer.
Opdivo is fully human immunoglobulin G4 (IgG4) monoclonal antibody that target programmed Death-1 receptor. By binding to PD-1, it inhibits its interaction with its natural ligands, PD-L1 and PD-L2. PD-1 is an immune checkpoint receptor that negatively regulates T-cell activation and function. When PD-1 binds to PD-L1 or PD-L2 molecules found on antigen-presenting cells, more often on tumor cells, it suppresses T-cell proliferation and cytokine production, thereby limiting the immune response.
By blocking PD-1 from connecting with its ligands, nivolumab restores and enhances T-cell activity, which promotes anti-tumor immune responses.
Due to its broader cancer indications, approved for almost 20+ cancers, its global recognition, almost approved in 60+ countries, undergone 1000+ clinical trials worldwide and massive commercial success almost generated 1 billion annual revenue Nivolumab (Opdivo) is one of the most well-known and widely used anticancer drugs globally, especially in the field of immune-oncology.
Clinical Trial-CheckMate-67T Trial
The CheckMate-67T trial was a pivotal Phase 3 study that led to the approval of subcutaneous nivolumab in the UK.
The CheckMate-67T trial was a pivotal Phase 3, randomized, open-label, multicenter study designed to evaluate the efficacy, safety, and pharmacokinetics of a new subcutaneous (SC) formulation of nivolumab, compared to its standard intravenous (IV) formulation. The trial enrolled 495 patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC), all of whom had received up to two prior systemic therapies. Patients were randomized to receive either SC nivolumab at 1200 mg every four weeks, co-formulated with recombinant human hyaluronidase (rHuPH20), or IV nivolumab at 3 mg/kg every two weeks.
The primary endpoints focused on comparing pharmacokinetics between the two formulations. The SC version demonstrated noninferior serum drug levels, with a geometric mean ratio for the 28-day average concentration of 2.098 and a trough steady-state concentration ratio of 1.774 compared to IV nivolumab. These results confirmed that the SC formulation delivers adequate and sustained drug levels in the bloodstream.
In terms of efficacy, the objective response rate (ORR) evaluated by blinded independent central review was 24.2% in the SC group and 18.2% in the IV group. Median progression-free survival (PFS) was also slightly better in the SC arm (7.23 months) compared to the IV arm (5.65 months), indicating at least comparable clinical benefit.
The safety profile of the SC formulation was consistent with that of IV nivolumab. Grade 3–4 adverse events were reported in 35.2% of SC-treated patients versus 40.8% in the IV group. Treatment-related adverse events occurred in 9.7% of patients in the SC arm and 14.7% in the IV arm. While injection site reactions occurred in 8.1% of SC patients, these were all low-grade and transient.
Overall, the CheckMate-67T trial established that the subcutaneous formulation of nivolumab offers a comparable safety and efficacy profile to the traditional IV infusion, with the added benefit of a much shorter administration time (3–5 minutes).
Impact of this approval on Patient and Healthcare System
The approval of the subcutaneous (SC) injectable form of nivolumab, administered in just 3–5 minutes, represents a significant advancement not only in cancer immunotherapy but also in the operational efficiency of healthcare systems.
Operational Efficiency
Oncology centres can treat more patients per day, improving access and reducing waiting lists, especially critical in high-demand settings.
Subcutaneous delivery bypasses the need for IV lines, infusion pumps, and extended monitoring.
The switch from a 30–60 minute IV infusion to a 3–5 minute SC injection frees up infusion chairs and resources significantly.
Workforce and Nursing Burden
Reduced Nursing Time: Nurses spend less time preparing, administering, and monitoring SC injections than IV infusions
Simplified Workflow: SC administration is quicker and easier to train and perform, reducing staff fatigue and increasing capacity.
Financial and Economic Impact
Lower Resource Utilization: Shorter administration time and less equipment usage lower direct costs.
Reduced Hospital Stay/Daycare Costs: Especially beneficial in settings where infusion visits are billed by duration or require hospital resources.
Potential to Shift to Community/At-Home Care: Future models may allow SC nivolumab to be delivered in community settings, reducing hospital dependency even further.
Patient Experience and Convenience
Reduces time spent at the hospital from over an hour to just minute a major improvement for working patients and caregivers.
Fewer disruptions to daily life, particularly beneficial for patients receiving long-term or adjuvant immunotherapy
Patients prefer less invasive, faster treatments. This translates into higher satisfaction and potentially better adherence, which is crucial for chronic or prolonged regimens.
Given nivolumab’s approvals across 15+ cancer types (e.g., NSCLC, melanoma, RCC, bladder, oesophageal, head and neck), it is used in thousands of patients weekly in oncology clinics worldwide. The frequency of its use amplifies the system-level benefits:
System-Wide Impact: Even minor time and cost savings per patient scale dramatically across large populations.
Increased Flexibility in Scheduling: Reduces bottlenecks in oncology services.
Improved Continuity of Care: Less clinic fatigue and improved morale for both patients and healthcare workers
Conclusion
The approval of the 3–5 minute subcutaneous (SC) injectable form of nivolumab marks a pivotal advancement in cancer care, blending clinical efficacy with logistical innovation. By delivering comparable safety, pharmacokinetics, and anti-tumor activity to the intravenous formulation while reducing administration time, this new approach addresses several critical challenges in modern oncology.
Its benefits are multifold: patients gain convenience, comfort, and reduced treatment burden; clinicians and nurses experience lower workload and increased efficiency; and healthcare systems benefit from optimized resource utilization, cost containment, and expanded capacity. For a drug like nivolumab, already approved for various cancers, these improvements are especially impactful given the large and growing patient population receiving immunotherapy.
Looking ahead, the SC formulation of nivolumab sets a new standard for biologic cancer therapies. It concretizes the way for more accessible outpatient and potentially home-based cancer care models. As the oncology field continues to prioritize patient-centric, high-efficiency solutions, this advancement is not just a technical improvement; it is a strategic leap toward the future of cancer treatment.
References
NHS rolls out 5-minute ‘super-jab’ for 15 cancers, NHS England, 30 April 2025, https://www.england.nhs.uk/2025/04/nhs-rolls-out-5-minute-super-jab-for-15-cancers/
MHRA authorises cancer treatment variation with an administration time of 3–5 minutes, Medicines and Healthcare products Regulatory Agency, 30 April 2025, https://www.gov.uk/government/news/mhra-authorises-cancer-treatment-variation-with-an-administration-time-of-3-5-minutes
Summary of Product Characteristics, Opdivo, Bristol-Myers Squibb Pharma EEIG, https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf
Saby George 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. JCO 42, LBA360-LBA360 (2024). DOI:10.1200/JCO.2024.42.4_suppl.LBA360
L. Albiges, MT Bourlon de los Rios, M. Chacon 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, Annals of Oncology, Volume 35, Supplement 2S1013-S1014September 2024
Subcutaneous Nivolumab (nivolumab and hyaluronidase) Shows Noninferiority Compared to Intravenous Opdivo (nivolumab) in Advanced or Metastatic Clear Cell Renal Cell Carcinoma in CheckMate -67T Trial, Bristol, Myers Squibb, 27 Jan 2024 https://news.bms.com/news/details/2024/Subcutaneous-Nivolumab-nivolumab-and-hyaluronidase-Shows-Noninferiority-Compared-to-Intravenous-Opdivo-nivolumab-in-Advanced-or-Metastatic-Clear-Cell-Renal-Cell-Carcinoma-in-CheckMate–67T-Trial/default.aspx
Joshi DC, Sharma A, Prasad S, et al. Novel therapeutic agents in clinical trials: emerging approaches in cancer therapy. Discover Oncology. 2024 Aug 11; 15(1):342.
Ryan Scot, The subcutaneous approval of opdivo makes waves in future of cancer care, Jan 15 2025, https://www.curetoday.com/view/the-subcutaneous-approval-of-opdivo-makes-waves-in-future-of-cancer-care
Subcutaneous Nivolumab Reduces Burden of Melanoma Care, Expert Says, 13 March 2025, Oncology News Centre, https://www.oncologynewscentral.com/melanoma/subcutaneous-nivolumab-reduces-burden-of-melanoma-care-expert-says
Bristol Myers Squibb Receives MHRA Approval for the Subcutaneous Formulation of Opdivo (nivolumab), FirstWorld Pharma, https://firstwordpharma.com/story/5955874
The article is extensively reviewed and fact-checked by the editorial team of pharmacally.com
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