FDA approves neratinib with capecitabine for metastatic, HER2-positive breast cancer

The Food and Drug Administration has approved the use of the targeted therapy neratinib (Nerlynx) with the chemotherapy pill capecitabine (Xeloda) for people with metastatic, HER2-positive breast cancer that has grown through at least two past lines of treatment. This marks the second FDA approval for people with this type of metastatic breast cancer in less than 6 months.

Neratinib is a tyrosine kinase inhibitor previously approved to treat early-stage HER2-positive breast cancer when cancer remains after treatment with trastuzumab (Herceptin) and chemotherapy.

The new approval is based on results from the NALA trial that were first presented at the American Society of Clinical Oncology Annual Meeting in June 2019. The phase III, open label trial randomized 621 people to get capecitabine and either neratinib or lapatinib (Tykerb), another tyrosine kinase inhibitor already approved for this use.

Researchers set co-primary endpoints (goals) for the NALA trial of progression free survival — how long people went without the cancer growing —and overall survival — how long people went without dying of any cause. The treatment met both endpoints.

A year after being randomized, cancer had not grown in

• 29 percent of people given neratinib
• 15 percent of people given lapatinib

Neratinib also led to longer overall survival:

• The neratinib group lived 21 months on average.
• The lapatinib group lived 18.7 months on average.

The most common side effect was diarrhea, which was reported by 83 percent of those in the neratinib group. In the study, people assigned to neratinib and capecitabine also received antidiarrheal medicine. Nausea, vomiting, and hand-foot syndrome were also common.

What this means for you

Neratinib was one of several medicines last year being studied in people with metastatic breast cancer that had grown despite previous treatments. While there are well-studied standards of care for the first few lines of treatment, much less is known about what to do after they have been exhausted.

If you have metastatic, HER2-positive breast cancer, the approval of neratinib is another option after cancer growth following targeted treatments like trastuzumab. When you change treatments, ask your doctor what they recommend, and the reasons why. If you think you may be able to take neratinib and capecitabine, ask your doctor why they would or would not recommend it for you.