The Food and Drug Administration approval provides another option for cancer patients

December 27, 2024 (Sacramento, California) The FDA has approved a new administration option for the immunotherapy, nivolumab (Opdivo) with hyaluronidase-nvhy (Opdivo Qvantig). Previously, the drug was given only as an intravenous infusion, but it will now become available as a subcutaneous injection. The decision provides another option to include in the formulary.

The approval could boost the convenience of patients receiving treatment with nivolumab. The approval covers adults with solid tumors where nivolumab is indicated as monotherapy or monotherapy maintenance following completion of nivolumab plus ipilimumab (Yervoy) combination therapy, or in combination with chemotherapy or cabozantinib. It cannot be used in combination with ipilimumab.

Nivolumab delivered intravenously was initially approved for use in the U.S. on December 22, 2014. Cancer cells take advantage of the body’s ability to control and shut off a T-cell’s response. They hijack the system that prevents autoimmunity, to their advantage. With nivolumab preventing the shut-off, the T-cell remains active to recognize and eliminate the cancer cell.

It is an antibody created to find and bind to the programmed death receptor (PD-1) located on the membrane of activated T cells. The binding of nivolumab to PD-1 physically prevents the interaction between the cancer cell and the immune cell, which would normally cause a shut-off to the immune cell’s response.

The new approval covers melanoma, colorectal cancer, esophageal adenocarcinoma, esophageal carcinoma, head and neck squamous cell carcinoma, hepatocellular carcinoma, gastric cancer, gastroesophageal junction cancer, non-small cell lung cancer, renal cell carcinoma, and urothelial carcinoma.

The subcutaneous therapy was evaluated by treating patients with advanced/metastatic clear cell renal cell carcinoma in the CheckMate 67T (NCT04810078) trial, a phase III, open-label, multicenter, noninferiority trial. The results showed that the objective response rate of the subcutaneous nivolumab was slightly above that of the intravenous nivolumab. The pharmacokinetics (drug metabolism) showing relative drug exposure (the relative levels of drug found in the body) were similar, but exposures were higher for the subcutaneous administration. Safety profiles were consistent between the subcutaneous and intravenous administrations. Overall, the data showed that subcutaneous nivolumab was non-inferior to intravenous nivolumab.

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About AIM at Melanoma and AIM at Skin Cancer
From its modest roots operating out of the living room of its founder, Valerie Guild, after she lost her 26-year-old daughter to melanoma, AIM at Melanoma has grown to be a global foundation whose work focuses on three critical areas: innovative and collaborative research; legislation, policy, and advocacy; and education. AIM at Skin Cancer, an entity of AIM at Melanoma, had its genesis in Valerie Guild’s same initial belief: patients, their caregivers, and their families need comprehensive, accurate and up-to-date information on their disease and treatment options in order to be active participants in treatment and care.

AIM at Melanoma’s global research initiatives include The International Melanoma Tissue Bank Consortium, The Melanoma International Collaboration for Adaptive Trials, and The International Melanoma Working Group. Founded in 2004, AIM at Melanoma is dedicated to finding more effective treatments and, ultimately, the cure for melanoma while improving the lives of those it affects. For more information, visit www.AIMatMelanoma.org and follow our groundbreaking initiatives on Facebook, Instagram, Twitter, and YouTube.

About Melanoma
Melanoma is one of the fastest-growing cancers in the United States and worldwide. It’s one of the most complex forms of cancer and has the most mutations of all solid cancers. In the U.S., melanoma is the fifth most common cancer in both men and women. Incidence rates are higher in women than in men before the age of 50, but by age 65, rates in men double those in women, and by age 80 they are triple.