On December 27, 2024, the FDA announced a significant milestone in cancer treatment: the approval of nivolumab and hyaluronidase-nvhy (Opdivo Qvantig) for subcutaneous injection. This new formulation is available for all adult solid tumor indications previously approved for intravenous (IV) nivolumab, including a wide range of cancers such as melanoma, renal cell carcinoma, non-small cell lung cancer, and others. With this approval, patients and providers now have access to a faster, more convenient way to administer a cornerstone immunotherapy.
The Shift to Subcutaneous Administration
Traditionally, nivolumab has been administered as an IV infusion, often taking up to 30 minutes. While this time frame may seem relatively short, for many patients undergoing regular treatment, it adds up. Subcutaneous nivolumab, administered via a quick injection, dramatically reduces chair time for patients and eases the burden on infusion centers.
This shift aligns with the growing emphasis on improving the patient experience in oncology care—making treatments not only effective but also less intrusive to patients’ daily lives.
Efficacy and Safety: Insights from CHECKMATE-67T
The approval is supported by data from the CHECKMATE-67T trial, a multicenter, randomized, open-label study that compared subcutaneous nivolumab (with hyaluronidase) to IV nivolumab in patients with advanced or metastatic clear cell renal cell carcinoma. Key findings include:
- Pharmacokinetics: The subcutaneous formulation met predefined equivalence margins for drug exposure, demonstrating similar efficacy to IV administration.
- Objective Response Rate (ORR):
- Subcutaneous nivolumab: 24% (95% CI: 19, 30).
- Intravenous nivolumab: 18% (95% CI: 14, 24).
- Safety Profile: The most common adverse reactions were consistent across both arms, including fatigue, musculoskeletal pain, pruritus, rash, and cough.
These findings confirm that subcutaneous nivolumab offers comparable efficacy and safety to the IV formulation, with the added benefit of convenience.
Recommended Dosage and Schedule
The dosing for subcutaneous nivolumab varies depending on the specific cancer indication. The recommended regimens are as follows:
- Every 2 weeks: 600 mg nivolumab and 10,000 units hyaluronidase.
- Every 3 weeks: 900 mg nivolumab and 15,000 units hyaluronidase.
- Every 4 weeks: 1,200 mg nivolumab and 20,000 units hyaluronidase.
Treatment continues until disease progression, unacceptable toxicity, or as specified for individual indications in the prescribing information.
What This Means for Patients and Providers
The availability of subcutaneous nivolumab is a significant advance in oncology care for several reasons:
- Enhanced Patient Convenience: With a quick injection, patients spend less time in the clinic, making treatment less disruptive to their daily lives.
- Optimized Clinic Efficiency: Shortened administration times reduce infusion center bottlenecks, allowing clinics to accommodate more patients or allocate resources elsewhere.
- Patient Comfort: Many patients prefer a simple injection over the need for IV access, particularly those with difficult veins or prior port complications.
Collaborative Efforts: A Global Approval Process
This approval was part of Project Orbis, an FDA initiative that fosters international collaboration in reviewing oncology drugs. Regulatory agencies from Canada and Israel were involved in this review, highlighting the global effort to bring innovative treatments to patients more quickly.
The FDA approval of subcutaneous nivolumab is more than a technical adjustment; it’s a leap forward in patient-centered cancer care. By offering a treatment option that’s equally effective but significantly more convenient, this new formulation underscores the ongoing commitment to improving quality of life for cancer patients.
About the author
Dr. Sajeve Thomas is a distinguished medical professional and a compassionate guide in the field of oncology. With over a decade of dedicated experience as a board-certified medical oncologist/internal medicine specialist, Dr. Thomas has become a trusted expert in the treatment of melanoma, sarcoma, and gastrointestinal conditions. He brings a wealth of expertise to the complex and challenging world of oncology.