Tukysa - opinion on variation to marketing authorisation
Opinion
EMA has issued an opinion on a change to this medicine's authorisation
tucatinib
Post-authorisationHuman
On 15 October 2026 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Tukysa. The marketing authorisation holder for this medicinal product is Pfizer Europe MA EEIG.
The CHMP adopted a new indication as follows:
HER2-positive breast cancer
Tukysa is indicated in combination with trastuzumab and pertuzumab for the maintenance treatment of adult patients with unresectable or metastatic HER2-positive breast cancer following first-line chemotherapy.
For information, the full indications for Tukysa will be as follows:
HER2-positive breast cancer
Tukysa is indicated in combination with trastuzumab and pertuzumab for the maintenance treatment of adult patients with unresectable or metastatic HER2-positive breast cancer following first-line chemotherapy.
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.
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
Note: New text in bold.