Nivolumab/hyaluronidase
Nivolumab and hyaluronidase-nvhy (Opdivo Qvantig) for subcutaneous injection is a combination agent with nivolumab, an anti-programmed death receptor-1 (PD-1) monoclonal antibody, and hyaluronidase, an endoglycosidase. The addition of the hyaluronidase allows the primary active agent, nivolumab, to be administered as a subcutaneous injection. This is different from nivolumab, which is typically administered intravenously. The initial approval for the subcutaneous injection of nivolumab and hyaluronidase-nvhy occurred in 2024.
Nivolumab is a PD-1-targeting antibody that binds to PD-1, a checkpoint control. PD-1 is a negative regulator of T-cell activation and proliferation, which is exploited by cancer cells. This means that PD-1 engagement will turn the immune response off, essentially acting as a brake to an immune reaction. Cancer cells thriving in the presence of immune cells have exploited this biological mechanism for their survival.
The ability to shut off an immune response exists to prevent an allergic reaction (e.g. from dust, pollen, or insect stings) from killing the organism by way of a cytokine storm and immune overreaction. However, cancer cells use the shut off inappropriately for their benefit. For this reason, nivolumab-containing agents are known as immune checkpoints or immune checkpoint inhibitors.
The hyaluronidase is an endoglycosidase component co-administered with nivolumab. It is used to increase the dispersion and absorption of the drug when administered subcutaneously. This addition of hyaluronidase with nivolumab constitutes this product as a different drug that classic nivolumab, which is administered intravenously.
Note: The indications for the subcutaneous injection of nivolumab and hyaluronidase-nvhy are approved under accelerated approval based on overall response rate and duration of response. For the continued approval of this agent, it requires verification and proof of clinical benefit in confirmatory trials.
It is indicated for use with specific caveats on recurrence, respectability and tumor sizes in:
- Colorectal cancer
- Esophageal cancer
- Gastric cancer
- Gastroesophageal junction cancer
- Hepatocellular carcinoma
- Melanoma
- Non-small cell lung cancer
- Renal cell carcinoma
- Squamous cell carcinoma of the head and neck
- Urothelial carcinoma
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