Tukysa (tucatinib)
- Region
- 🇪🇺 EU
- Active substance
- tucatinib
- Company
- Pfizer Europe MA EEIG
- Status
- Authorised
- Therapeutic area
- Breast Neoplasms; Neoplasm Metastasis
- CHMP opinion
- Thu 10 Dec 2020
- EU approval
- Thu 11 Feb 2021
- Application
- EMEA/H/C/005263
- ATC
- L01EH03
- Official record
- www.ema.europa.eu
Indication
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.