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NOW APPROVED

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TUKYSA® (tucatinib) is NOW APPROVED as a prescription medicine used in adults in combination with the medicines trastuzumab and pertuzumab for maintenance treatment of a type of breast cancer called human epidermal growth factor receptor-2 (HER2)-positive breast cancer that has spread to nearby tissue or lymph nodes and cannot be removed by surgery (unresectable locally advanced) or to other parts of the body (metastatic).
Your healthcare provider will perform a test to make sure TUKYSA is right for you.
It is not known if TUKYSA is safe and effective in children.
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I take the TUKYSA maintenance regimen* for me, and them

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*TUKYSA, trastuzumab, pertuzumab
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What is the TUKYSA maintenance regimen*?

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A chemo-free maintenance regimen that includes TUKYSA, trastuzumab, and pertuzumab for adults with HER2+ breast cancer that cannot be removed by surgery or has not grown or spread to other parts of the body following the initial phase of treatment

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*TUKYSA, trastuzumab, pertuzumab
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Continue your care with the TUKYSA maintenance regimen*

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If you are stable after completing your initial phase of treatment (your doctor may refer to this initial phase of treatment as induction) for HER2+ MBC, maintenance treatment with TUKYSA may be used to help you live longer without your cancer growing or spreading compared to trastuzumab and pertuzumab alone.

Initial phase of treatment: The first phase of treatment that helps stop the growth of or shrink cancer before maintenance treatment begins. In HER2+ MBC, this phase may include chemotherapy, trastuzumab, and pertuzumab.


*TUKYSA, trastuzumab, pertuzumab

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How the TUKYSA maintenance regimen* targets HER2

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TUKYSA, trastuzumab, and pertuzumab are each designed to target HER2, but they work in different ways.

TUKYSA targets HER2 from inside the cell, while trastuzumab and pertuzumab target HER2 differently from outside the cell.

Since HER2 is also present on normal cells, HER2-targeted therapies like TUKYSA can affect normal cells, which may cause side effects. Some side effects may be serious.


*TUKYSA, trastuzumab, pertuzumab

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How was TUKYSA studied?

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TUKYSA was studied in a clinical trial called HER2CLIMB-05

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Who was in the trial?

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The trial included 654 adults with HER2+ breast cancer that could not be removed by surgery or had spread to other parts of the body, and who had completed their initial phase of treatment (induction) with trastuzumab, pertuzumab, and a taxane, and showed no signs of cancer progression. People with a presence or history of brain metastases were included provided they were stable, had no symptoms, and did not require immediate local treatment.
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What treatments did they receive?

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People were randomly assigned to a treatment group:

  • 326 people received TUKYSA + trastuzumab + pertuzumab
  • 328 people received a placebo + trastuzumab + pertuzumab

Endocrine therapy was permitted for people with HR+ disease.

Antidiarrheal medicine was allowed but not required.

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The TUKYSA maintenance regimen* helped people live longer without their cancer progressing

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*TUKYSA, trastuzumab, pertuzumab
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Not real patients.
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Median progression-free survival

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People taking TUKYSA + trastuzumab + pertuzumab had an 8.6-month longer median progression-free survival than people taking placebo + trastuzumab + pertuzumab.

Median: The midpoint of a set of numbers, with half of the values below the median and half above it.

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Number of people who lived without their cancer growing or spreading

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185 out of 326 people (57%) who took TUKYSA + trastuzumab + pertuzumab lived without their cancer growing or spreading.
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137 out of 328 people (42%) who took placebo + trastuzumab + pertuzumab lived without their cancer growing or spreading.
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What are the possible side effects?

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You may experience side effects during treatment

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Serious side effects

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Some side effects can be serious and should be treated by your doctor as soon as possible.

  • 17% of people taking TUKYSA, trastuzumab, and pertuzumab experienced serious side effects
  • The most common serious side effects were liver problems
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Treatment changes due to side effects

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  • 49% of people had their treatment temporarily paused
  • 29% of people had their treatment dose reduced
  • 14% of people had to permanently stop treatment
  • The most common side effects leading to treatment changes were liver problems and diarrhea
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Common side effects

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  • diarrhea
  • muscle and joint pain
  • liver problems
  • nausea
  • tiredness
  • rash
  • vomiting
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More about side effects

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  • These are not all of the possible side effects of TUKYSA, and you may also get side effects from the other medicines taken with TUKYSA
  • Nearly everyone in the trial had some side effects
  • TUKYSA may cause fertility problems in males and females, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility
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Talk to your doctor for help with side effects

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Many side effects can be managed with support from your doctor. It’s important to talk to your care team about how you’re feeling. They can help.