Seagen’s sNDA for Tukysa plus Trastuzumab Gets Priority Review

The FDA has granted a Priority Review to Seagen’s supplemental New Drug Application (sNDA) for Tukysa (tucatinib) in combination with trastuzumab for adult patients with HER2-positive colorectal cancer who have received at least one prior treatment regimen for unresectable or metastatic disease.

An oral tyrosine kinase inhibitor of the HER2 protein, Tukysa is currently indicated for use 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.

The FDA has set a target action date of Jan. 19, 2023 for the sNDA. There are currently no FDA-approved treatments for metastatic colorectal cancer that specifically target HER2.