JANUARY 24, 2023

Tucatinib Approved as First Treatment for HER2-Positive Metastatic CRC

The FDA granted accelerated approval for tucatinib (Tukysa, Seagen) in combination with trastuzumab for adult patients with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer that has progressed after treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. This is the first FDA-approved treatment in HER2-positive metastatic colorectal cancer.


“Historically, patients with HER2-positive metastatic colorectal cancer who have progressed