Regulatory approval

Published by the Food and Drug Administration. Approved

TUKYSA is a kinase inhibitor 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 [see Clinical Studies (14.2)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

This is written in the approval document.

Citation

Seagen Inc. Tukysa (tucatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213411s004lbl.pdf. Revised January 2023. Accessed October 30, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	HER2-positive, Wild type KRAS, Wild type NRAS	Colorectal Adenocarcinoma	Trastuzumab, Tucatinib

Contributions

Date	Contributor	Description
2025-10-03	Van Allen lab	On 2023-01-19 the FDA granted accelerated approval to tucatinib in combination with trastuzumab for the treatment of adult patients with RAS wild-type HER2-positive unresectable or metastatic colorectal cancer.
2023-01-19	Food and Drug Administration	Indication received traditional approval.