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Medical Daily
Medical Daily
Health
Dorothy Brooks

Tukysa Wins FDA Nod for First-Line HER2-Positive Breast Cancer Maintenance After Trial Showed 8.6-Month Longer Median Disease Control

Adults with metastatic HER2-positive breast cancer now have a new FDA-approved way to extend the calmer phase of treatment that follows chemotherapy. On Oct. 7, the U.S. Food and Drug Administration approved tucatinib, sold as Tukysa, with trastuzumab and pertuzumab as maintenance therapy for adults with unresectable locally advanced or metastatic HER2-positive breast cancer following induction treatment.

The decision moves the oral drug into first-line care. Tukysa was first approved in 2020, with trastuzumab and capecitabine, for patients who had already received anti-HER2 treatment for metastatic disease, according to Pfizer's announcement. The new label applies earlier, once a patient's cancer has been brought under control.

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