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Tukysa Approval History

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

Tukysa (tucatinib) is a kinase inhibitor indicated in combination with trastuzumab and capecitabine for the treatment of patients with advanced unresectable or metastatic HER2-positive breast cancer.

Development History and FDA Approval Process for Tukysa

DateArticle
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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