Neratinib Receives FDA Approval for Adjuvant Treatment After Surgery in HER2-Positive Breast Cancer

The United States Food and Drug Administration, FDA, approved neratinib (brand name Nerlynx) for HER2-positive early-stage breast cancer after trastuzumab (Herceptin), as adjuvant treatment to reduce the risk of the disease returning after surgery.

Approval was based on results from ExteNET, a multicenter, randomized, double-blind, placebo-controlled clinical trial . This trial enrolled 2840 women with early-stage HER2-positive breast cancer who had completed adjuvant trastuzumab within 2 years. Half received neratinib for 1 year; the others formed the control group.

According to the Clinical Trial Results:

At 2 years, disease-free survival, meaning survival without breast cancer recurrence, was 94.2% among patients receiving neratinib and 91.9% in the control group. Common treatment-related adverse effectsincluded diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, mouth inflammation, reduced appetite, muscle spasms, indigestion, increased blood AST and ALT, nail disorders, dry skin, abdominal swelling, weight loss, and urinary tract infection. The most common adverse effect was diarrhea. It occurred in 16.8 percent of patients and treatment was discontinued in these patients.

How Does Neratinib Work?

Neratinib is a tyrosine kinase inhibitor. It irreversibly inhibits the tyrosine kinase activity of the intracellular portion of human epidermal growth factor receptors (EGFR, HER2, HER4), thereby suppressing growth and proliferation signals within cancer cells.

The recommended neratinib dose is a total of 240 mg daily for 1 year (6 tablets taken by mouth with food 1 time per day). Because diarrhea is common, routine supportive antidiarrheal treatment, such as loperamide, is recommended alongside neratinib for the first 56 days.

In conclusion, when added to standard protective treatment after surgery for early-stage HER2-positive breast cancer, neratinib significantly improved treatment success and therefore received FDA approval . We are following the approval process for this new breast cancer treatment in our country and will share further developments.