Pharmaceutical compound
| Combination of | |
|---|---|
| Nivolumab | Programmed death receptor-1-blocking antibody |
| Hyaluronidase | Endoglycosidase |
| Clinical data | |
| Trade names | Opdivo Qvantig |
| Other names | Nivolumab/hyaluronidase-nvhy |
| License data | |
| Routes of administration | Subcutaneous injection |
| ATC code |
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| Legal status | |
| Legal status |
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Nivolumab/hyaluronidase, sold under the brand name Opdivo Qvantig, is a fixed-dose combination anti-cancer medication used for the treatment of various forms of cancer. Nivolumab/hyaluronidase contains nivolumab, a programmed death receptor-1 (PD-1)-blocking monoclonal antibody; and hyaluronidase, an endoglycosidase. It is given by subcutaneous injection.
Nivolumab/hyaluronidase was approved for medical use in the United States in December 2024.
Medical uses
In December 2024, the US Food and Drug Administration (FDA) approved the combination of nivolumab and hyaluronidase across approved adult, solid tumor nivolumab indications as monotherapy, monotherapy maintenance following completion of hyaluronidase plus ipilimumab combination therapy, or in combination with chemotherapy or cabozantinib. The approval includes indications for renal cell carcinoma, melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, urothelial carcinoma, colorectal cancer, hepatocellular carcinoma, esophageal carcinoma, gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.
History
The subcutaneous injection of nivolumab and hyaluronidase was evaluated in CHECKMATE-67T (NCT04810078), a multicenter, randomized, open-label trial in participants with advanced or metastatic clear cell renal cell carcinoma who received no more than two prior systemic treatment regimens. A total of 495 participants were randomized to receive either subcutaneous nivolumab and hyaluronidase or intravenous nivolumab.
Society and culture
Legal status
Nivolumab/hyaluronidase was approved for medical use in the United States in December 2024.
References
- ^ "Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) injection, for subcutaneous use" (PDF). Bristol-Myers Squibb Company. December 2024.
- ^ "FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injection". U.S. Food and Drug Administration (FDA). 27 December 2024. Archived from the original on 27 December 2024. Retrieved 28 December 2024.
This article incorporates text from this source, which is in the public domain.
- "U.S. Food and Drug Administration Approves Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) Injection, for Subcutaneous Use in Most Previously Approved Adult, Solid Tumor Opdivo (nivolumab) Indications1,2" (Press release). Bristol Myers Squibb. 27 December 2024. Archived from the original on 27 December 2024. Retrieved 28 December 2024 – via Business Wire.
External links
- Clinical trial number NCT04810078 for "A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread (CheckMate-67T)" at ClinicalTrials.gov
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| PD-1 inhibitorsTooltip Programmed cell death protein 1 | |
| PD-L1 inhibitorsTooltip Programmed death-ligand 1 | |
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