NEW YORK CITY (dpa-AFX) - Pfizer Inc. (PFE) announced that the U.S. Food and Drug Administration (FDA) approved TUKYSA in combination with trastuzumab and pertuzumab for maintenance treatment of adults with unresectable, locally advanced, or metastatic human epidermal growth factor 2-positive (HER2+) breast cancer after induction treatment.
TUKYSA (tucatinib) is an oral HER2-targeted tyrosine kinase inhibitor.
The approval was supported by the key results from the HER2CLIMB-05 Phase 3 Trial. According to the company, TUKYSA in combination with trastuzumab and pertuzumab improved median progression-free survival by more than 50% compared with trastuzumab and pertuzumab alone.
It was previously approved in combination with trastuzumab and capecitabine for adults with previously treated HER2-positive advanced unresectable or metastatic breast cancer, including patients with brain metastases.
The latest approval expands TUKYSA into the front-line setting, where it is used with trastuzumab and pertuzumab as maintenance therapy following induction treatment.
PFE has traded between $23.62 and $ 29.21 over the last year. The stock closed Wednesday's trade at $28, up 1.82%.
In the overnight market, PFE is up 0.04% at $28.01.
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