Opdivo Qvantig FDA Approval History

FDA Approved: Yes (First approved December 27, 2024)
Brand name: Opdivo Qvantig
Generic name: nivolumab and hyaluronidase-nvhy
Dosage form: Subcutaneous Injection
Company: Bristol-Myers Squibb Company
Treatment for: Renal Cell Carcinoma, Melanoma, Non Small Cell Lung Cancer, Head and Neck Cancer, Urothelial Carcinoma, Colorectal Cancer, Hepatocellular Carcinoma, Esophageal Carcinoma, Gastric Cancer

Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) is a programmed death receptor-1 (PD-1)-blocking antibody and hyaluronidase combination for use in the treatment of renal cell carcinoma, melanoma, non-small cell lung cancer, squamous cell carcinoma of the head and neck, urothelial carcinoma, colorectal cancer, hepatocellular carcinoma, esophageal cancer, gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

• Opdivo Qvantig is indicated for the treatment of:
  Renal Cell Carcinoma (RCC)
  • adult patients with intermediate or poor risk advanced RCC, as a first-line treatment following combination treatment with intravenous nivolumab and ipilimumab.
  Limitations of Use: Opdivo Qvantig is not indicated in combination with ipilimumab for the treatment of renal cell carcinoma.
  • adult patients with advanced RCC, as a first-line treatment in combination with cabozantinib.
  • adult patients with advanced RCC who have received prior anti-angiogenic therapy.
  Melanoma
  • adult patients with unresectable or metastatic melanoma.
  • adult patients with unresectable or metastatic melanoma following combination treatment with intravenous nivolumab and ipilimumab.
  Limitations of Use: Opdivo Qvantig is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic melanoma.
  • for the adjuvant treatment of adult patients with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.
  Non-Small Cell Lung Cancer (NSCLC)
  • adult patients with resectable (tumors ≥4 cm or node positive) NSCLC in the neoadjuvant setting, in combination with platinum-doublet chemotherapy.
  • adult patients with resectable (tumors ≥4 cm or node positive) NSCLC and no known EGFR mutations or ALK rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by Opdivo Qvantig monotherapy as adjuvant treatment after surgery.
  • adult patients with metastatic NSCLC and progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Opdivo Qvantig.
  Limitations of Use: Opdivo Qvantig is not indicated in combination with ipilimumab for the treatment of metastatic NSCLC.
  Squamous Cell Carcinoma of the Head and Neck (SCCHN)
  • adult patients with recurrent or metastatic SCCHN with disease progression on or after a platinum-based therapy.
  Urothelial Carcinoma (UC)
  • adjuvant treatment of adult patients with UC who are at high risk of recurrence after undergoing radical resection of UC.
  • adult patients with unresectable or metastatic urothelial carcinoma, as first-line treatment in combination with cisplatin and gemcitabine.
  • adult patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
  Colorectal Cancer
  • adult patients with MSI-H or dMMR metastatic CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, as monotherapy or as monotherapy following combination treatment with intravenous nivolumab and ipilimumab.
  Limitations of Use: Opdivo Qvantig is not indicated in combination with ipilimumab for the treatment of MSI-H or dMMR metastatic CRC.
  Hepatocellular Carcinoma (HCC)
  • adult patients with HCC previously treated with sorafenib and following combination treatment with intravenous nivolumab and ipilimumab.
  Limitations of Use: Opdivo Qvantig is not indicated in combination with ipilimumab for the treatment of HCC.
  Esophageal Cancer
  • adult patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, who have received neoadjuvant chemoradiotherapy (CRT).
  • adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma as first-line treatment in combination with fluoropyrimidine- and platinumcontaining chemotherapy.
  Limitations of Use: Opdivo Qvantig is not indicated in combination with ipilimumab for the treatment of patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
  • adult patients with unresectable advanced, recurrent or metastatic ESCC after prior fluoropyrimidine- and platinum-based chemotherapy.
  Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma
  • adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma in combination with fluoropyrimidine- and platinum-containing chemotherapy.
  This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Development timeline for Opdivo Qvantig

Further information

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