TUKYSA tucatinib

Drug Class

HER2 tyrosine kinase inhibitor

Mechanism

Selectively inhibits the kinase domain of HER2 receptor, blocking downstream MAPK and AKT signaling pathways that drive tumor cell growth.

Approved Indication

FDA-approved in combination with trastuzumab and capecitabine for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens.

What This Means For Patients

TUKYSA is an oral small-molecule inhibitor of HER2. It is approved by the FDA and EMA for advanced HER2-positive breast cancer (including brain metastases) and is accessible in Hainan Boao Lecheng.

Regulatory Approvals

• FDA — approved (2020) — label
• EMA — approved (2021) — source

Pivotal Clinical Evidence

• HER2CLIMB — Murthy et al., N Engl J Med 2020 (NCT02614794) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213411s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/tukysa