The U.S. Food and Drug Administration (FDA) has approved Tukysa (tucatinib) in combination with trastuzumab for treating adult patients with HER2-positive colorectal cancer. This approval is specifically for patients who have previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
The approval is based on results from the HER2CLIMB-02 trial, a global, multicenter study that enrolled 84 patients. Participants received either the Tukysa-trastuzumab combination or standard chemotherapy. The trial showed a confirmed objective response rate (ORR) of 38% in the Tukysa group, with a median duration of response of 12.4 months. In contrast, the ORR for chemotherapy alone was significantly lower, at 0%.
“This approval represents an important advance for patients with previously treated HER2-positive metastatic colorectal cancer, offering an off-the-shelf, oral-targeted treatment option,” said Dr. John Strickler, associate professor of medicine at Duke University Medical Center and the lead investigator in the HER2CLIMB-02 trial.
Tukysa is marketed by Seagen Inc., a biotechnology company based in Bothell, Washington. It belongs to a class of drugs known as tyrosine kinase inhibitors and is already approved for certain types of breast cancer.
HER2-positive colorectal cancer is relatively rare, affecting approximately 3% to 5% of all metastatic colorectal cancer cases. The new approval provides a valuable treatment option for this specific group of patients.
