The FDA has approved tucatinib (Tukysa) in combination with trastuzumab and pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic HER2-positive breast cancer. The approval follows induction treatment for this patient population.
The combination is specifically indicated for patients whose disease has not progressed after initial therapy. The FDA's announcement did not include new efficacy data in the summary, but the approval adds a targeted oral option to the maintenance setting.
This decision gives clinicians a defined follow-up regimen for HER2-positive advanced breast cancer, a setting where maintenance therapy is intended to extend disease control after initial response.