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EMA Validates and Grants Accelerated Assessment for Trastuzumab Deruxtecan for the Treatment of HER2 Positive Metastatic Breast Cancer

 Trastuzumab deruxtecan is presently unlicensed in the European region

Tokyo and Munich - (Monday 6 July, 2020) – Daiichi Sankyo Company, Limited (hereafter, Daiichi

Sankyo) and AstraZeneca today announced that the European Medicines Agency (EMA) has granted

Trastuzumab deruxtecan accelerated assessment by the EMA’s Committee for Medicinal Products for

Human Use (CHMP). Validation confirms that the application is complete and commences the scientific

review process by the EMA’s CHMP. Trastuzumab deruxtecan is a HER2 directed antibody conjugate

(ADC). The application is for the assessment of trastuzumab deruxtecan’s use in the treatment of adults

with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti

HER2 based regimens.

“The accelerated assessment highlights the significant unmet need for patients with HER2 positive

metastatic breast cancer that trastuzumab deruxtecan aims at addressing,” said Gilles Gallant, BPharm,

PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi

Sankyo. “Trastuzumab deruxtecan is already available for patients in the U.S. and Japan and we look

forward to working with the EMA to bring this important new medicine to patients in the EU as quickly as


The marketing authorisation application (MAA) is based on the positive results from the pivotal phase 2

DESTINY-Breast01 trial of trastuzumab deruxtecan monotherapy in patients with HER2 positive

metastatic breast cancer who had received two or more prior anti-HER2 regimens. The results of the trial

are published in The New England Journal of Medicine.i

About HER2

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of

tumours including gastric, breast and lung cancers. HER2 overexpression is associated with a specific

HER2 gene alteration known as HER2 amplification and is often associated with aggressive disease and

poorer prognosis.ii

DSC/20/0093 For pharmaceutical and medical trade press only

July 2020

About HER2 Positive Breast Cancer

Approximately 15-30 per cent of breast cancers are HER2 positive.ii Despite recent improvements and

approvals of new medicines, there remain significant clinical needs for patients with HER2 positive

metastatic breast cancer.iii,iv This disease remains incurable with patients eventually progressing after

available treatment.iv

About Trastuzumab Deruxtecan

Trastuzumab deruxtecan (fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC and

is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in

AstraZeneca’s ADC Scientific platform.

ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy (“payload”) to cancer cells via a

linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells.v

Designed using Daiichi Sankyo’s proprietary DXd ADC technology, trastuzumab deruxtecan is comprised

of a HER2 monoclonal antibody attached to a novel topoisomerase I inhibitor payload by a tetrapeptidebased


Trastuzumab deruxtecan (5.4 mg/kg) is approved in the U.S. for the treatment of adult patients with

unresectable or metastatic HER2 positive breast cancer who received two or more prior anti-HER2-based

regimens based on the DESTINY-Breast01 trial. It is also currently approved in Japan for the treatment of

patients with HER2 positive unresectable or recurrent breast cancer after prior chemotherapy.

Trastuzumab deruxtecan has not been approved in the EU, or countries outside Japan or the United

States, for any indication.

About the Collaboration between Daiichi Sankyo and AstraZeneca

In March 2019, Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and

commercialise trastuzumab deruxtecan worldwide, except in Japan where Daiichi Sankyo maintains

exclusive rights. Daiichi Sankyo is solely responsible for the manufacturing and supply.

About Daiichi Sankyo UK

Daiichi Sankyo UK Ltd is a UK affiliate company with corporate origins in Japan. We create and supply

innovative products to help the NHS to deliver better patient care in the fields of cardiovascular disease

and oncology.

Our company was founded in 2006 through the merger of Japanese companies Daiichi and Sankyo in

Europe. With a rich legacy of scientific expertise dating back more than 100 years, we are the pioneer

behind leading pharmaceuticals that have contributed to the improvement of countless lives across the


Our mission is to contribute to the enrichment of quality of life through the discovery and delivery of

innovative medicines that address diverse and unmet medical needs.

We are committed to providing innovation that demonstrates value and supports the NHS in its delivery of

sustainable high-quality care, enabling efforts to reduce health inequalities and unwarranted variations

and which puts the patient at the heart of the service.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery,

development and commercialisation of prescription medicines, primarily for the treatment of diseases in

three therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory. AstraZeneca

operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

AstraZeneca operates in five different locations in the UK, where around 8,300 employees work in

research and development, manufacturing, supply, sales and marketing. We supply 40 different medicines

to the NHS. The UK is also an important location for AstraZeneca’s clinical trials; in 2018, we undertook

201 trials in the UK, involving 376 centres and over 7,000 patients.

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Last Updated: 08-Jul-2020