Tucatinib

TUKYSA (tucatinib) is indicated in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received prior treatment with trastuzumab, pertuzumab, and trastuzumab emtansine, separately or in combination.

Clinical trial data supporting the effectiveness of TUKYSA in combination with trastuzumab and capecitabine are limited to patients who had received at least one prior HER2-directed therapy in the metastatic setting. 1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.

2 Geriatrics Geriatrics (≥65 years of age): In the HER2CLIMB trial, 116/612 (19%) patients were 65 years or older. No overall differences in effectiveness were observed between these patients and younger patients. Differences in safety were observed between patients 65 years or older and younger patients in the TUKYSA arm; patients 65 years or older were more likely to experience a serious adverse event and more likely to discontinue TUKYSA compared to younger patients <65 years (see Warnings and Precautions Special Populations, Geriatrics).

TUKYSA is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least 2 prior anti-HER2 treatment regimens.