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Daiichi Sankyo and AstraZeneca's breast cancer drug Enhertu approved in UK

Published on 16/02/21 at 10:33am

Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) has been granted conditional authorisation in the UK as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer, who have received two or more prior anti-HER2-based regimens.

Almost 54,000 cases of breast cancer in women are diagnosed annually in the UK, with an estimated one in five cases being HER2-positive. Breast cancer is responsible for approximately 12,000 deaths every year, and there are an estimated 35,000 people living with metastatic breast cancer in the UK.

The UK’s authorisation is based on the results of the Phase II DESTINY-Breast01 trial of trastuzumab deruxtecan in 184 patients with HER2-positive metastatic breast cancer. Results from the data cut-off in June last year demonstrated a confirmed objective response rate of 61.4%, including a 6.5% complete response rate and a 54.9% partial response rate.

Appraisals of trastuzumab deruxtecan by the NICE and the Scottish Medicines Consortium are currently underway, and NHS access decisions are expected later this year.

Dr Rebecca Roylance, Consultant Medical Oncologist at UCLH, said: “One in five women with breast cancer have HER2-positive disease. Though significant treatment advances have been made, there has been no clear standard of care for patients with metastatic HER2-positive disease following progression on first and second-line treatment and many patients do not have a durable response to other available later-line treatment options.

“The authorisation of trastuzumab deruxtecan by the MHRA and EMA brings a new treatment option to patients and their doctors in the UK.”

Arun Krishna, Head of Oncology at AstraZeneca UK, also commented: “The DESTINY-Breast01 trial showed a duration of response not previously seen in patients after progression on first and second line treatment.

“Trastuzumab deruxtecan is an important new treatment option for patients at this stage of care and will shift clinical discussions towards a focus on targeted treatment. This is the first new cancer medicine to be authorised by the MHRA in 2021 and our focus now is on securing access for NHS patients as quickly as possible.”

Darcy Jimenez

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