June 25, 2024

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FDA approved Nerlynx for HER2-positive breast cancer

FDA approved Nerlynx for HER2-positive breast cancer


FDA approved Nerlynx for the treatment of early HER2-positive breast cancer. If you are diagnosed with early HER2-positive breast cancer, Nerlynx may be useful.

Nerlynx (chemical name: neratinib) was approved by the U.S. Food and Drug Administration (FDA) on July 17, 2017 for the treatment of early HER2-positive breast cancer with extended periods after surgery (doctors call this extended adjuvant therapy ) People who have previously received Herceptin treatment (chemical name: trastuzumab).

Nerlynx is the first drug specifically designed for prolonged adjuvant treatment of early HER2-positive disease.  Nerlynx fights HER2-positive breast cancer by blocking the ability of cancer cells to receive growth signals. Nerlynx is an oral pill.

FDA approved Nerlynx for HER2-positive breast cancer


HER2-positive breast cancer makes HER2 protein too much. The HER2 protein is located on the surface of cancer cells and receives signals that tell cancer to grow and spread. About one in four breast cancers is HER2-positive. Compared with HER2-negative breast cancer, HER2-positive breast cancer tends to be more aggressive and more difficult to treat.

Herceptin works by attaching to the HER2 protein and preventing it from receiving growth signals. Herceptin is injected intravenously and approved by the U.S. Food and Drug Administration (FDA):

  • Treatment of advanced HER2-positive breast cancer
  • Give women with early HER2-positive disease as adjuvant therapy (treatment after initial treatment, such as surgery), alone or as part of a chemotherapy regimen

A newer form of Herceptin, Herceptin Hylecta (chemical name: trastuzumab and hyaluronidase oysk), can be given as an injection.


The recommended dose of Nerlynx is 240 mg (6 tablets) per day for 1 year.

The FDA approval is based on the results of ExteNET research. The study found that Nerlynx can improve disease-free survival after giving women diagnosed with early HER2-positive breast cancer and chemotherapy including Herceptin within 2 years after surgery. After 2 years of follow-up, the disease-free survival rate was:

  • 93.9% of women treated with Nerlynx
  • 91.6% of women treated with placebo (a fake drug that looks like Nerlynx but does not contain drugs)

This difference is statistically significant, which means it may be due to Nerlynx treatment and not just by chance.

Disease-free survival refers to how long a woman lives without cancer growth.

Severe diarrhea shortly after starting Nerlynx is a very common side effect. In the ExteNET trial, approximately 40% of women treated with Nerlynx had severe diarrhea, which is a side effect.

The FDA approved the recommendation to give Nerlynx loperamide (brand names include Imodium, Kaopectate 1-D and Pepto Diarrhea Control) during the first 56 days of treatment, and then help control diarrhea as needed.

Other common side effects of Nerlynx are vomiting, nausea, abdominal pain, fatigue, skin rash and mouth sores.

In rare cases, Nerlynx may cause serious liver problems. If you have any of the following signs of liver problems, tell your doctor immediately:

  • Yellow skin or white eyes
  • Black or brown urine
  • Feeling very tired
  • Lack of appetite
  • Pain in the upper right of the abdomen
  • Bleeding or bruising more easily than normal

“Despite advances in the treatment of early HER2-positive breast cancer, further treatment improvements are still needed to try to further reduce the risk of disease recurrence,” said Alan H. Auerbach, CEO and President of Puma Biotechnology. “We are very happy to bring this new drug to breast cancer patients. We are grateful to patients, caregivers and doctors who have contributed to the neratinib clinical development program, and more specifically, we have contributed to the ExteNET trial.”


(source:chinanet, reference only)

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