FDA approves tucatinib combo for HER2-positive breast cancer maintenance
The agency cleared tucatinib with trastuzumab and pertuzumab as a maintenance therapy following induction treatment, the FDA said.
The FDA approved tucatinib, sold as Tukysa by Seagen Inc., a subsidiary of Pfizer, on October 7, 2026. The approval covers use of tucatinib in combination with trastuzumab and pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic HER2-positive breast cancer following induction.1
The approval places tucatinib into a maintenance setting for patients who have already undergone induction treatment, rather than as an initial therapy line.
The FDA's announcement identifies the drug by both its generic name, tucatinib, and its brand name, Tukysa, and notes the drug's manufacturer relationship as a subsidiary of Pfizer. No additional details on trial data, dosing specifics, or further regulatory timelines were included in the available record.
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