What is Tukysa? | Information & FAQ

Last updated: 15 March 2022

What is Tukysa? | Information & FAQ

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Article reviewed by Dr. Jan de Witt

What is Tukysa (tucatinib)?

Tukysa (tucatinib) is a medication used in combination with trastuzumab and capecitabine for the treatment of adult patients human epidermal growth factor receptor 2 (HER2) -positive breast cancer that is advanced, unresectable or metastatic. Tukysa (tucatinib) is a tyrosine kinase inhibitor (targeted therapy) that targets HER2 found on some type of breast cancer cells. 1

How much does Tukysa (tucatinib) cost?

For more information about how much Tukysa (tucatinib) costs and how we can help you access it, please click on the button below:

What is Tukysa (tucatinib) used for?

Tukysa (tucatinib) is used in combination with chemotherapy (trastuzumab and capecitabine) for the treatment of adult patients with advanced, inoperable or metastatic HER2-positive breast cancer. This is including patients with cancer that has spread to the brain, and who have received previous treatment with three other cancer medicines.1

Is Tukysa (tucatinib) FDA approved?

Tukysa (tucatinib) in combination with trastuzumab and capecitabine for the treatment of adult patients with previously treated inoperable or metastatic HER2-positive breast cancer was approved by:

  • The Food and Drug Administration (FDA), USA, on April 17, 2020.2
  • Swissmedic, Switzerland, on May 12, 2020.3
  • Health Science Authority, Singapore on May 19, 2020. 4
  • Health Canada, Canada, on June 3, 2020.5
  • Therapeutic Goods Administration (TGA), Australia, on August 12, 2020.6

The FDA granted Tukysa Priority Review and Breakthrough Therapy designation, which are intended to encourage development of drugs to treat a serious condition. Tukysa was also granted Fast Tracks and Orphan Drug designations, which are intended to stimulate the development of drugs for treatment of serious and rare diseases. 2

Tukysa (tucatinib) is the first medication that has been approved under Project Orbis. This project may help patients with cancer gain earlier access to products in other countries where there may be significant delays in regulatory submissions, regardless of whether the product has received FDA approval.

Who makes Tukysa (tucatinib)?

Tukysa (tucatinib) is made by Seattle Genetics, also known as Seagen Inc. Seagen Inc. is an American biotechnology company focused on developing and commercializing innovative, empowered monoclonal antibody-based therapies for the treatment of cancer.


  1. Tukysa (tucatinib)- Thesocialmedwork.com
  2. Press release Tukysa - Fda.gov
  3. Investor.seagen.com
  4. Hsa.gov.sg
  5. Seattle Genetics, Inc. [PDF]
  6. Project Orbis - Fda.gov

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