Tucatinib: clinical trials recruiting now

FDA drug label

FDA-approved

Yes. Tucatinib appears in the FDA drug-label database. Marketed as TUKYSA.

Drug class

Kinase Inhibitor (FDA established pharmacologic class)

Mechanism of action

Tyrosine Kinase Inhibitors; Cytochrome P450 3A Inhibitors; P-Glycoprotein Inhibitors; Cytochrome P450 2C8 Inhibitors (as stated on the FDA label)

FDA-approved use

TUKYSA is a kinase inhibitor 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. ( 1.1 ) • 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. ( 1.2 ) This indication is approved under accelerated approval based on tumor response rate and durability of response [see Clinical Studies (14.2) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. 1.1 Metastatic Breast 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 s…

FDA label via openFDA