Nivolumab and Hyaluronidase-nvhy

(nih-VOL-yoo-mab … HY-al-yoo-RAH-nih-days)

Nivolumab and hyaluronidase-nvhy works by binding to and blocking the protein PD-1 on the surface of some cancer cells, which keeps cancer cells from suppressing the immune system. This allows the immune system to attack the cancer cells. Hyaluronidase is a recombinant human form of an enzyme that breaks down a substance in the body called hyaluronic acid. This increases the absorption of drugs into tissue. Nivolumab and hyaluronidase-nvhy is a form of nivolumab that is given as an injection under the skin. This form can be given in less time than nivolumab, which is given through a vein. Nivolumab and hyaluronidase-nvhy is a type of immunotherapy drug called an immune checkpoint inhibitor.

US Brand Name(s)

Opdivo Qvantig

FDA Approved

Yes

FDA label information for this drug is available at DailyMed.

Use in Cancer

Nivolumab and hyaluronidase-nvhy is approved to be used alone or with other drugs to treat adults with:

colorectal cancer. Nivolumab and hyaluronidase-nvhy is used alone to treat microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) cancer that has spread to other parts of the body and got worse after treatment with a fluoropyrimidine, oxaliplatin, and irinotecan hydrochloride. It may be used after treatment with nivolumab and ipilimumab.
esophageal cancer or gastroesophageal junction cancer. Nivolumab and hyaluronidase-nvhy is used:
- for esophageal or gastroesophageal junction cancer that has been treated with a combination of chemotherapy and radiation therapy and then surgery to completely remove the cancer, but cancer cells were found in the removed tumor or lymph nodes
- for squamous cell carcinoma of the esophagus that cannot be removed by surgery or has spread or come back after treatment with a fluoropyrimidine and platinum-based chemotherapy
- for squamous cell carcinoma of the esophagus that cannot be removed by surgery or has spread to other parts of the body. It is given with a fluoropyrimidine and platinum-based chemotherapy as the first treatment
gastric (stomach) cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma that has spread. Nivolumab and hyaluronidase-nvhy is used with a fluoropyrimidine and platinum-based chemotherapy.¹
hepatocellular carcinoma in patients whose cancer was treated with sorafenib tosylate and after treatment with nivolumab and ipilimumab
melanoma. Nivolumab and hyaluronidase-nvhy is used:
- for cancer that has spread or cannot be removed by surgery
- for cancer that has spread or cannot be removed by surgery and has been treated with ipilimumab and nivolumab
- as adjuvant therapy in patients with one of the following stages of melanoma that has been completely removed by surgery: stage IIB, IIC, IIIA, IIIB, IIIC, IIID, or IV melanoma
non-small cell lung cancer. Nivolumab and hyaluronidase-nvhy is used:
- with platinum-based chemotherapy before surgery for early-stage cancer
- with platinum-based chemotherapy before surgery for early-stage cancer that does not have an abnormal EGFR or ALK gene and then alone after surgery
- alone for cancer that has spread to other parts of the body and has gotten worse during or after treatment with platinum-based chemotherapy. Patients whose cancer has an abnormal EGFR or ALK gene should receive nivolumab and hyaluronidase-nvhy only if their cancer got worse after treatment with FDA-approved therapy for these gene mutations.
renal cell carcinoma (a type of kidney cancer) that is advanced. Nivolumab and hyaluronidase-nvhy is used:
- in patients who have already received angiogenesis inhibitor therapy
- with cabozantinib-s-malate as the first treatment
- as the first treatment in some patients who have been treated with ipilimumab and nivolumab
squamous cell carcinoma of the head and neck that has spread to other parts of the body or has come back and got worse during or after treatment with platinum-based chemotherapy
urothelial carcinoma (a type of cancer in the bladder or urinary tract). Nivolumab and hyaluronidase-nvhy is used:
- with cisplatin and gemcitabine hydrochloride as the first treatment for cancer that cannot be removed by surgery or has spread to other parts of the body
- after surgery to remove cancer that has a high risk of coming back
- for cancer that has spread and was treated with platinum-based chemotherapy, but it did not work, is no longer working, or the cancer has gotten worse

¹This use is approved under FDA’s Accelerated Approval Program. As a condition of approval, confirmatory trial(s) must show that nivolumab and hyaluronidase-nvhy provides a clinical benefit in these patients.

For information about nivolumab that may apply to nivolumab and hyaluronidase-nvhy, see the Drug Information Summary for Nivolumab.

Nivolumab and hyaluronidase-nvhy is also being studied in the treatment of other types of cancer.

More About Nivolumab and Hyaluronidase-nvhy

Definition from the NCI Drug Dictionary - Detailed scientific definition and other names for this drug.

Research Results and Related Resources

FDA Approves Injectable Nivolumab, an Alternative to IV Infusion

Targeted Therapy to Treat Cancer

Clinical Trials Accepting Patients

Find Clinical Trials for Nivolumab And Hyaluronidase-nvhy - Check for trials from NCI's list of cancer clinical trials now accepting patients.