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Tukysa FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 24, 2023.

FDA Approved: Yes (First approved April 17, 2020)
Brand name: Tukysa
Generic name: tucatinib
Dosage form: Tablets
Company: Seattle Genetics, Inc.
Treatment for: Breast Cancer, Colorectal Cancer

Tukysa (tucatinib) is a kinase inhibitor used for the combination treatment of HER2-positive breast cancer and RAS wild-type HER2-positive colorectal cancer.

  • Tukysa is indicated:
    • in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.
    • in combination with trastuzumab for the treatment of adult patients with RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
      This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
  • Tukysa contains tucatinib, which is a tyrosine kinase inhibitor of HER2. It works by inhibiting the growth of HER2 expressing tumors. The combination of tucatinib and trastuzumab demonstrated increased anti-tumor activity compared to each of the drugs used individually. 
  • Tukysa tablets are administered orally, twice daily.
  • Warnings and precautions associated with Tukysa include severe diarrhea, hepatotoxicity, and embryo-fetal toxicity.
  • Common adverse reactions with Tukysa in combination with trastuzumab and capecitabine in patients with metastatic breast cancer include diarrhea, palmar-plantar erythrodysesthesia, nausea, hepatotoxicity, vomiting, stomatitis, decreased appetite, anemia, and rash.
    Common adverse reactions with Tukysa in combination with trastuzumab in patients with unresectable or metastatic colorectal cancer include diarrhea, fatigue, rash, nausea, abdominal pain, infusion related reactions, and pyrexia.

Development timeline for Tukysa

DateArticle
Jan 19, 2023Approval Seagen Announces FDA Accelerated Approval of Tukysa (tucatinib) in Combination with Trastuzumab for People with Previously Treated RAS Wild-Type, HER2-Positive Metastatic Colorectal Cancer
Apr 17, 2020Approval FDA Approves Tukysa (tucatinib) for People with Advanced Unresectable or Metastatic HER2-Positive Breast Cancer
Feb 13, 2020Seattle Genetics Announces FDA Filing Acceptance for Priority Review of Tucatinib New Drug Application (NDA) for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer
Dec 23, 2019Seattle Genetics Announces Submission of Tucatinib New Drug Application to the U.S. FDA for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer
Dec 11, 2019Seattle Genetics Announces Positive Tucatinib HER2CLIMB Trial Results in Locally Advanced or Metastatic HER2-Positive Breast Cancer Presented at 2019 SABCS and Published in the New England Journal of Medicine
Oct 21, 2019Seattle Genetics Announces Positive Topline Results from Pivotal Trial of Tucatinib in Locally Advanced or Metastatic HER2-Positive Breast Cancer
Sep 29, 2019Initial Results from MOUNTAINEER Trial Show Antitumor Activity of Tucatinib Combination in HER2-Positive Metastatic Colorectal Cancer
Sep 27, 2017Cascadian Therapeutics Announces FDA Orphan Drug Designation Granted to Tucatinib for the Treatment of HER2+ Metastatic Colorectal Cancer
Jun  8, 2017Cascadian Therapeutics' Lead Candidate, Tucatinib, Receives Orphan Drug Designation from FDA for Treatment of Breast Cancer Patients with Brain Metastases

Further information

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