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 not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• FDA — Approved (2020) — Sources
• EMA — Approved (2021) — Sources

Pivotal Clinical Evidence

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

Sources

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