FDA approves Tukysa regimen for HER2+ metastatic breast cancer

By Katherine Hamilton Pfizer said the Food and Drug Administration approved Tukysa as a front-line maintenance treatment for people with a form of breast cancer. Tukysa was approved in combination with trastuzumab and pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic human epidermal growth factor 2-positive breast cancer following induction treatment. The approval expands the use of Tukysa to use during an earlier stage of metastatic disease, the drug company said Wednesday. Tukysa was first approved in 2020 for metastatic breast cancer. In a Phase 3 trial, patients treated with Tukysa showed 36% reduction in the risk of disease progression or death following induction treatment. The safety and tolerability was generally consistent with its known safety profile, with the exception of increased severity of hepatotoxicity, a form of liver damage caused by medications, Pfizer said. Write to Katherine Hamilton at katherine.hamilton@wsj.com (END) Dow Jones Newswires October 07, 2026 13:14 ET (17:14 GMT) Copyright (c) 2026 Dow Jones & Company, Inc. The statements in this document shall not be considered as an objective or independent explanation of the matters. Please note that this document (a) has not been prepared in accordance with legal requirements designed to promote the independence of investment research, and (b) is not subject to any prohibition on dealing ahead of the dissemination or publication of investment research.