The U.S. Food and Drug Administration has approved neratinib for the extended adjuvant treatment of early-stage, HER2-positive breast cancer.

For patients with this type of cancer, neratinib is the first extended adjuvant therapy, a form of therapy that is taken after an initial treatment to further lower the risk of the cancer coming back.

Neratinib is indicated for adult patients who have been previously treated with a regimen that includes the drug trastuzumab.

“HER2-positive breast cancers are aggressive tumours and can spread to other parts of the body, making adjuvant therapy an important part of the treatment plan,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Haematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Now, these patients have an option after initial treatment that may help keep the cancer from coming back.”

Breast cancer is the most common form of cancer in the United States.

The National Cancer Institute (NCI) estimates approximately 252,710 women will be diagnosed with breast cancer this year, and 40,610 will die of the disease. According to the NCI, approximately 15 percent of patients with breast cancer have tumours that are HER2-positive.    

Neratinib is a kinase inhibitor that works by blocking several enzymes that promote cell growth.

The safety and efficacy of neratinib were studied in a randomised trial of 2,840 patients with early-stage, HER2-positive breast cancer who completed treatment with trastuzumab within the previous two years.

The study measured the amount of time after the start of the trial that it took for the cancer to come back or for death to occur from any cause (invasive, disease-free survival).

After two years, 94.2 percent of patients treated with neratinib had not experienced cancer recurrence or death compared with 91.9 percent of patients receiving placebo.

Common side effects of neratinib include diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, swollen and sore mouth (stomatitis), decreased appetite, muscle spasms, indigestion (dyspepsia), liver damage (AST or ALT enzyme increase), nail disorder, dry skin, abdominal swelling (distention), weight loss and urinary tract infection.

Source: FDA