FDA NEWS: HER2CLIMB-05 Update

Picked by The OncoAlert NetworkFDA

Take-home: On October 7, 2026, the FDA approved tucatinib with trastuzumab and pertuzumab as maintenance treatment for adults with unresectable locally advanced or metastatic HER2-positive breast cancer after induction therapy. In HER2CLIMB-05, tucatinib significantly improved median PFS versus placebo (24.9 vs 16.3 months; HR 0.64, p<0.0001) in 654 patients, including those with brain metastases. OS data were immature.

OncoAlert infographic announcing FDA approval of tucatinib for HER2-positive advanced or metastatic breast cancer, highlighting HER2CLIMB-05 trial results.

About this highlight

Type
Regulatory news
Topic
Breast

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