July 18 (UPI) -- The U.S. Food and Drug Administration today approved the use of Nerlynx to treat early-stage HER2-positive breast cancer to lower remission risk.
Breast cancer is the most common form of cancer in the United States with the National Cancer Institute, or NCI, estimates 252,710 women will be diagnosed with breast cancer in 2017 and 40,610 will die of breast cancer.
Approximately 15 percent of breast cancer patients with tumors are HER2-positive.
"HER2-positive breast cancers are aggressive tumors and can spread to other parts of the body, making adjuvant therapy an important part of the treatment plan," Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a press release. "Now, these patients have an option after initial treatment that may help keep the cancer from coming back."
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Nerlynx, or neratinib, is the first extended adjuvant therapy, a type of therapy that is taken after initial treatment to further lower the risk of recurrence, for HER2-positive breast cancer. It works by blocking several enzymes that promote cell growth.
The FDA approved the use of Nerlynx for adult patients who have been previously treated with the drug trastuzumab.
Researchers studied the safety and effectiveness of Nerlynx in a clinical trial of 2,840 patients with early-stage HER2-positive breast cancer who had been treated with trastuzumab two years prior.
The study showed that after two years, 94.2 percent of patients treated with Nerlynx did not have a recurrence of breast cancer or death compared to 91.9 percent in patients taking a placebo.
