Article · Health news
FDA approves tucatinib for HER2 breast cancer
The US FDA approved tucatinib (Tukysa) on 7 October 2026 with trastuzumab and pertuzumab as maintenance treatment for advanced HER2-positive breast cancer.
Key points
- The US FDA approved tucatinib (Tukysa) on 7 October 2026.
- It is used with trastuzumab and pertuzumab as maintenance treatment for HER2-positive breast cancer that is unresectable, locally advanced or metastatic.
- The approved use follows induction therapy.
- This is a US decision; UK availability is decided separately.
What was announced
On 7 October 2026 the US Food and Drug Administration (FDA) approved tucatinib (Tukysa, Seagen, a subsidiary of Pfizer) in combination with trastuzumab and pertuzumab.
It is approved as maintenance treatment for adults with unresectable, locally advanced or metastatic HER2-positive breast cancer that has been treated with induction therapy.
What it means
In the trial, patients received tucatinib or placebo together with trastuzumab and pertuzumab.
This is a US decision; availability in the UK is decided separately by the MHRA and NICE.
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