FDA approves drug to reduce risk of HER2-positive breast cancer returning

The US Food and Drug Administration (FDA) has approved neratinib (Nerlynx; Puma Biotechnology) as the first extended adjuvant therapy for early-stage, HER2-positive breast cancer.

Neratinib is a kinase inhibitor that works by blocking several enzymes that promote cell growth. It is a form of therapy that is taken after initial treatment to further lower the risk of the cancer coming back. It is indicated for adult patients who have been previously treated with trastuzumab (Herceptin; Genentech).

Richard Pazdur, director of FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products within the FDA’s Center for Drug Evaluation and Research, said: “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.”

“Now, these patients have an option after initial treatment that may help keep the cancer from coming back,” he added.

The safety and efficacy of neratinib was studied in a randomised control trial involving 2,840 patients with early-stage, HER2-positive breast cancer who had been treated with a regimen of trastuzumab in the last two years. Researchers measured the amount of time after the trial that it took for the cancer to come back or for death to occur. After two years, 94.2% of patients had not experienced recurrence or death, compared with 91.9% of patients who had received placebo.

Common side effects included diarrhoea, nausea, abdominal pain and fatigue.