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Seagen's breast cancer drug TUKYSA gets UK approval

Published on 22/02/21 at 08:59am
Image credit: Business Wire

The MHRA has granted marketing authorisation in the UK for Seagen’s TUKYSA (tucatinib) 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 two prior anti-HER2 treatment regimens.

The European centralised marketing authorisation granted by the European Commission for TUKYSA is valid in Northern Ireland. MHRA had previously granted a Promising Innovative Medicine designation to the drug, which is an oral, small molecule tyrosine kinase inhibitor (TKI) of HER2, a protein that contributes to cancer cell growth.

The UK authorisation is based on results from the pivotal trial HER2CLIMB, a randomised, double-blind, placebo-controlled, active comparator, global trial. The study enrolled 612 with HER2-positive unresectable locally advanced or metastatic breast cancer who had previously received, either separately or in combination, trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1). 

Dr Alicia Okines, Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, said: “Every year, an estimated 55,000 people are diagnosed with breast cancer in the UK, of which up to one in five are estimated to have HER2-positive tumours. The authorisation of tucatinib in combination with trastuzumab and capecitabine is a significant step forward for adult patients with advanced, incurable HER2-positive breast cancer.

“With this authorisation, our patients, including those with disease that has spread to the brain, may have a new alternative therapeutic option that offers a meaningful survival benefit with a generally manageable side effect profile.”

Clay Siegall, CEO at Seagen, also commented: “The TUKYSA combination is a landmark therapy for patients with HER2-positive metastatic breast cancer with or without brain metastases, extending overall survival in these patients after two prior anti-HER2-treatment regimens.

“We are pleased TUKYSA is now authorised in the UK, and we look forward to further collaborating with the national reimbursement bodies to ensure it is available to adult patients.”

Darcy Jimenez

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