FDA Approves Neratinib for Early-Stage HER2-Positive Breast Cancer

The medicine can reduce risk of recurrence slightly after treatment with trastuzumab and chemotherapy
Breast Cancer News
September 15, 2017
Erin Rowley, Writer and Content Coordinator
Reviewed By: 
Filipa Lynce, MD

On July 17, the U.S. Food and Drug Administrationinfo-icon (FDAinfo-icon) announced approval of neratinib to treat people with early-stageinfo-icon HER2-positive breast cancer who have completed treatment with trastuzumabinfo-icon (Herceptininfo-icon) and chemotherapyinfo-icon. FDA approval means neratinib will now be widely available for doctors to use in breast cancer treatment. The pharmaceutical company Puma Biotechnology will sell neratinib under the brand name Nerlynx.


Neratinib is a tyrosine kinase inhibitor. It treats breast cancer by stopping HER2-positive cancer cells from growing.

The approval is based on the results of the phase III ExteNET study. This study included 2,840 women with early-stage HER2-positive breast cancer. The women finished treatment with the HER2-targeted therapyinfo-icon trastuzumab and chemotherapy within 2 years of enrolling in the trial. Half of the women were randomly assigned to take neratinib, a pill, every day for a year. The other half were randomly assigned to a daily placeboinfo-icon pill.

Two years after the women finished taking their trial medicineinfo-icon:

  • 91.6 percent of the placebo group was alive and hadn’t experienced an invasive recurrenceinfo-icon
  • 93.9 percent of the neratinib group was alive and hadn’t experienced an invasive recurrence

The study showed participants with cancer that was also hormone receptorinfo-icon-positive benefitted more from neratinib than those with hormone receptor-negative cancer.

The most common side effectinfo-icon of neratinib was diarrheainfo-icon, which more than 90 percent of the group taking the medicine experienced. Forty percent of the group taking the medicine had gradeinfo-icon 3 diarrhea, which is severe enough to warrant treatment in a hospital.

Nauseainfo-icon, fatigueinfo-icon, vomiting and stomach pain were also common with neratinib.

The FDA recommends taking the anti-diarrhea medicine loperamide (Imodium) during the first 56 days of treatment with neratinib, and as needed after that.

What This Means for You

Twenty years ago there were no FDA approved targeted therapies for HER2-positive breast cancer. But then came trastuzumab, lapatinibinfo-icon (Tykerbinfo-icon) pertuzumabinfo-icon (Perjeta), ado-trastuzumab emtansine (Kadcyla) and now, neratinib. You may feel relieved to know there are multiple treatment options for your breast cancer subtype.

FDA approval of neratinib means you have the option to continue treatment for another year. You may feel good about being able to lower your risk of recurrence with this new treatment. You may also worry about another year of treatment, and the side effects, such as diarrhea, and the potential financial impact that comes along with it.

If you’re in treatment or you recently finished treatment for early-stage HER2-positive breast cancer, talk to your oncologistinfo-icon about whether neratinib is an option for you and about the pros and cons of this newly-approved medicine.

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