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Update: FDA approves tucatinib (Tukysa) for metastatic Her2-positive breast cancer

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This report is about: 

approval of the drug tucatinib (Tukysa) in combination with chemotherapy for treating Her2-positive breast cancer.

Why is this approval important?

Recurrent Her2-positive breast cancer is an aggressive type of cancer with limited options, especially for people whose disease has spread to the brain. On April 17, 2020, the U.S. Food and Drug Administration () granted approval of Tukysa in combination with chemotherapy for the treatment of advanced,  breast cancer in people who have received at least one prior therapy for disease.

Research findings:

approval of Tukysa in combination with chemotherapy was based on previous research, which we reported in this XRAY review. The HER2CLIMB study looked at 612 patients with Her2-positive breast cancer. For participants who received Tukysa plus chemotherapy:

  • at 1 year, the risk of disease progression or death was 46 percent lower compared to the  group.
  • at 1 year, the risk of disease progression or death was 52 percent lower among participants with brain metastases compared to those in the  group.
  • at 2 years, the risk of death was 34 percent lower.
  • almost twice as many participants experienced a reduction in the size or a disappearance of their cancer compared to the  group.

Most adverse events that occurred were not severe, but included:

  • diarrhea
  • hand-foot syndrome
  • nausea
  • fatigue
  • vomiting

The warns that Tukysa can cause serious side effects, including severe diarrhea associated with dehydration, acute kidney and liver damage.

What does this mean for me?

If you have been diagnosed with locally advanced or   breast cancer, you may want to talk to your doctor about whether Tukysa is right for you.

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Approves First New Drug Under International Collaboration, A Treatment Option for Patients with Metastatic Breast Cancer. Website. April, 2020.


FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.


This article is relevant for:

Patients with Her2-positive metastatic breast cancer

This article is also relevant for:

people with breast cancer

people with Her2-positive cancer

men with breast cancer

people with metastatic or advanced cancer

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Expert Guidelines
Expert Guidelines

The National Comprehensive Cancer Network (NCCN) brings together national expert panels that creates guidelines for cancer treatment. NCCN breast cancer guidelines recommend the following treatments for people with metastatic breast cancer:

  • For hormone receptor positive cancers, NCCN recommends several different treatment options:
    • Hormone therapy with HER2-targeted therapy (for people who are post-menopausal or on drugs to suppress their ovaries).
    • HER2-targeted therapy with chemotherapy.
  • For hormone receptor negative cancers:
    • HER2-targeted therapy with chemotherapy.
  • For 2nd line therapy:
    • trastuzumab deruxtecan (ENHERTU) is preferred treatment.
    • tucatinib (Tukysa) with HER2-targeted therapy and chemotherapy (for people with brain or other central nervous system ).
  • For 3rd line and later therapy:
    • tucatinib (Tukysa) with HER2-targeted therapy and chemotherapy (especially in people with brain or other central nervous system ).
    • HER2-targeted therapy with chemotherapy.

Updated: 12/22/2021

Questions To Ask Your Doctor
Questions To Ask Your Doctor

  • Is Tuksya a treatment option for my type of breast cancer?
  • If Tukysa is not an option for me right now, might it be an option in the future?
  • What side effects might I experience with this treatment?
  • If I have serious side effects, will I need to stop treatment?
  • Are any other agents available to treat my cancer?

Open Clinical Trials
Open Clinical Trials

The following are studies looking at treatment for people with HER2-positive breast cancer.  

Other clinical trials for people with breast cancer can be found here.

Updated: 07/21/2022

Peer Support
Peer Support

The following organizations offer peer support services for people with, or at high risk for breast cancer:

Updated: 11/29/2022

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