Tucatinib
Tucatinib (Tukysa, Pfizer Europe MA EEIG) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: HER2 (1).
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Breast cancer1 | |||
HER2 IHC 3+ or IHC 2+/ISH-positive | + trastuzumab and capecitabine | 3L+ advanced | After at least 2 prior anti-HER2 treatment regimens |
Full text of section 4.1 (therapeutic indications)
TUKYSA is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least 2 prior anti-HER2 treatment regimens.
Label history
10 changes to the Tukysa label since 2022, none of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes