> FDA approves neratinib for early-stage HER2-positive breast cancer

FDA approves neratinib for early-stage HER2-positive breast cancer


The medicine can reduce risk of recurrence slightly after treatment with trastuzumab and chemotherapy

The U.S. Food and Drug Administration (FDA) announced approval of neratinib to treat people with early-stage HER2-positive breast cancer who have completed treatment with trastuzumab (Herceptin) and chemotherapy. 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 therapy 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 placebo pill.

Two years after the women finished taking their trial medicine:

  • 91.6 percent of the placebo group was alive and hadn’t experienced an invasive recurrence
  • 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 receptor-positive benefitted more from neratinib than those with hormone receptor-negative cancer.

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

Nausea, fatigue, 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, lapatinib (Tykerb), pertuzumab (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 oncologist about whether neratinib is an option for you and about the pros and cons of this newly-approved medicine.