Is OPDIVO QVANTIG approved for treating urothelial carcinoma by the FDA?
OPDIVO QVANTIG is a combination of nivolumab and hyaluronidase given as a subcutaneous injection. According to the FDA-approved labeling, its indications are limited to certain types of renal cell carcinoma and melanoma 1. Urothelial carcinoma is not listed among the approved uses. While nivolumab (the active drug in OPDIVO QVANTIG) has been studied and approved for urothelial carcinoma in its intravenous form 78, the subcutaneous formulation OPDIVO QVANTIG has not received FDA approval for this cancer type.
What the research says
The FDA-approved indications for OPDIVO QVANTIG are specifically for advanced renal cell carcinoma (as first-line treatment in combination with cabozantinib or after prior anti-angiogenic therapy) and for melanoma (unresectable or metastatic, and as adjuvant treatment after complete resection) 1. The prescribing information does not include urothelial carcinoma 1. In contrast, intravenous nivolumab (the same active antibody) was approved by the FDA in 2017 for advanced urothelial carcinoma 7. More recently, the CheckMate 274 trial showed that adjuvant intravenous nivolumab improves disease-free survival in high-risk muscle-invasive urothelial carcinoma after radical surgery 8. However, these approvals apply to the intravenous formulation, not to the subcutaneous OPDIVO QVANTIG. Other therapies for urothelial carcinoma include antibody-drug conjugates like disitamab vedotin, which has shown efficacy in HER2-low and HER2-negative advanced urothelial carcinoma 34, and immune checkpoint inhibitors such as atezolizumab 5. The European Association of Urology guidelines also recommend multidisciplinary management for muscle-invasive bladder cancer 6, but they do not list OPDIVO QVANTIG as a treatment option.
What to ask your doctor
- Is intravenous nivolumab an option for my type of urothelial carcinoma?
- What are the FDA-approved treatments for my specific stage and subtype of urothelial carcinoma?
- Are there clinical trials available for new therapies like antibody-drug conjugates or combination immunotherapy?
- How do the efficacy and side effects of subcutaneous OPDIVO QVANTIG compare with intravenous nivolumab for other cancers?
- Should I consider a second opinion at a cancer center that specializes in urothelial carcinoma?
This question is drawn from common patient questions about Urology and answered using cited medical research. We do not provide individualized advice.