New Formulation of Nivolumab Allows Subcutaneous Injection
The FDA approved nivolumab and hyaluronidase-nvhy as an injectable therapy for multiple tumor types.
The U.S. Food and Drug Administration (FDA) has approved nivolumab and hyaluronidase-nvhy (Opdivo Qvantig) for subcutaneous (under the skin) injection for solid tumor indications in which intravenous nivolumab (Opdivo) is approved, excluding combinations involving intravenous ipilimumab (Yervoy). This covers cancers of the bladder, colon and rectum, esophagus, head and neck, kidney, liver, lung, skin (melanoma), and stomach. The full list of FDA-approved indications for nivolumab and hyaluronidase-nvhy is available online.

Nivolumab is an immune checkpoint inhibitor, a type of immunotherapy that prevents cancer and other cells from shutting off a type of antitumor immune response, whereas hyaluronidase is an enzyme that degrades a component of the framework surrounding cells in order to increase permeability and allow a drug—in this case, nivolumab—to be better absorbed by tissues.
This approval was based on results from the multicenter, randomized, open-label phase III CheckMate-67T trial, in which 495 patients with advanced or metastatic clear cell renal cell carcinoma were randomly assigned to receive either subcutaneously injected nivolumab and hyaluronidase-nvhy or intravenous nivolumab. Patients were eligible if they had undergone fewer than three prior systemic therapies.
The trial met both of its endpoints, first demonstrating that subcutaneous nivolumab and hyaluronidase-nvhy led to similar serum concentrations of nivolumab compared to when nivolumab was administered intravenously. Additionally, the subcutaneous and intravenous administration routes led to similar response rates—24% and 18%, respectively, with no statistically significant difference—thus demonstrating that clinical efficacy was not compromised by the subcutaneous administration.
There are three recommended doses for nivolumab and hyaluronidase-nvhy, depending on the specific indication: 600 mg nivolumab and 10,000 units hyaluronidase every two weeks; 900 mg nivolumab and 15,000 units of hyaluronidase every three weeks; or 1,200 mg nivolumab and 20,000 units hyaluronidase every four weeks until disease progression, excessive toxicity, or according to prescribing information.
According to federal statistics, it was estimated that, collectively, more than 800,000 individuals would be diagnosed with cancers of the bladder, colon and rectum, esophagus, head and neck, kidney, liver, lung, skin (melanoma), and stomach in the United States in 2024, and approximately 286,680 would die of these diseases.
The FDA rendered its decision on December 27, 2024. Check this resource for updated information on all therapeutics regulated by the FDA.