Tukysa FDA Approval History
Last updated by Judith Stewart, BPharm on June 24, 2020.
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 Timeline for Tukysa
|Apr 17, 2020||Approval FDA Approves Tukysa (tucatinib) for People with Advanced Unresectable or Metastatic HER2-Positive Breast Cancer|
|Feb 13, 2020||Seattle 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, 2019||Seattle 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, 2019||Seattle 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, 2019||Seattle Genetics Announces Positive Topline Results from Pivotal Trial of Tucatinib in Locally Advanced or Metastatic HER2-Positive Breast Cancer|
|Sep 29, 2019||Initial Results from MOUNTAINEER Trial Show Antitumor Activity of Tucatinib Combination in HER2-Positive Metastatic Colorectal Cancer|
|Sep 27, 2017||Cascadian Therapeutics Announces FDA Orphan Drug Designation Granted to Tucatinib for the Treatment of HER2+ Metastatic Colorectal Cancer|
|Jun 8, 2017||Cascadian Therapeutics' Lead Candidate, Tucatinib, Receives Orphan Drug Designation from FDA for Treatment of Breast Cancer Patients with Brain Metastases|
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.