Indications of Tucatinib

1.Metastatic Breast Cancer

Tucatinib 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. 

2.Unresectable or Metastatic Colorectal Cancer

Tucatinib is indicated 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.

from FDA，2023.01