The U.S. Food and Drug Administration has approved Nerlynx (neratinib) from Puma Biotechnology for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. Nerlynx, a kinase inhibitor that works by blocking several enzymes that promote cell growth, is the first extended adjuvant therapy for this type of cancer.
Adjuvant therapy is taken after an initial treatment to further lower the risk of the cancer coming back. Nerlynx is for adult patients who have been previously treated with a regimen that includes the drug trastuzumab.
“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,” said Richard Pazdur, M.D., 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. “Now, these patients have an option after initial treatment that may help keep the cancer from coming back.”
The safety and efficacy of Nerlynx were studied in a randomized 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. After two years, 94.2 percent of patients treated with Nerlynx had not experienced cancer recurrence or death compared with 91.9 percent of patients receiving placebo.