# AstraZeneca´s Enhertu recommended for approval in the EU

- Link: https://www.directorstalkinterviews.com/astrazeneca%c2%b4s-enhertu-recommended-for-approval-in-the-eu/4121070308
- Published: 2022-06-27T08:39:19+01:00
- Author: Amilia Stone

**[AstraZeneca plc](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l)**(
[LON:AZN](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l))
and Daiichi Sankyo’s _Enhertu_ (trastuzumab deruxtecan) has been recommended for
approval in the European Union (EU) as a monotherapy for the treatment of adult 
patients with unresectable or metastatic HER2-positive breast cancer who have received
one or more prior anti-HER2-based regimens.

_Enhertu_ is a specifically engineered HER2-directed antibody drug conjugate (ADC)
being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) based its positive opinion on results from the DESTINY-Breast03 Phase
III trial, which were published in The New England Journal of Medicine.^(1) In the
trial, _Enhertu_ reduced the risk of disease progression or death by 72% versus 
trastuzumab emtansine (T-DM1) (hazard ratio [HR] 0.28; 95% confidence interval [
CI]: 0.22-0.37; p<0.0001) in patients with HER2-positive unresectable and/or metastatic
breast cancer previously treated with trastuzumab and a taxane.

In Europe, more than 530,000 cases of breast cancer are diagnosed annually.^(2) 
Approximately one in five cases of breast cancer are considered HER2-positive.^(
3) Despite initial treatment with trastuzumab, pertuzumab and a taxane, patients
with HER2-positive metastatic breast cancer will often experience disease progression.
^(4,5) More treatment options are needed to further delay progression and extend
survival.^(4,6,7)

> **Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said**:“
> This recommendation reflects the transformative progression-free survival benefit
> seen in the DESTINY-Breast03 trial compared to T-DM1, supporting _Enhertu_ as 
> a potential new standard of care and setting a new benchmark in the treatment 
> of HER2-positive metastatic breast cancer. If approved by the European Commission,
> patients in Europe may be able to benefit from this important medicine earlier
> in the treatment of their disease, improving their chance for better outcomes.”

> **Gilles Gallant, Senior Vice President, Global Head, Oncology Development, Oncology
> R&D, Daiichi Sankyo, said: **“Today’s CHMP opinion provides further validation
> of the significance of the DESTINY-Breast03 trial results, which for the first
> time showed superiority of _Enhertu_ in prolonging progression-free survival in
> patients previously treated for HER2-positive metastatic breast cancer as compared
> to another HER2-directed ADC. This positive CHMP opinion is an important step 
> forward in bringing this potentially practice-changing medicine to patients in
> Europe to use earlier in the treatment of HER2-positive metastatic breast cancer
> and builds on the recent approval of _Enhertu_ in the US.”

The recommendation will now be reviewed by the European Commission, which has the
authority to grant marketing authorisations for medicines in the EU.

_Enhertu_ is being further assessed in a comprehensive clinical development programme
evaluating efficacy and safety across multiple HER2-targetable cancers, including
breast, gastric, lung and colorectal cancers.

**_Enhertu_**

_Enhertu_ is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd
ADC technology, _Enhertu_ is the lead ADC in the oncology portfolio of Daiichi Sankyo
and the most advanced programme in AstraZeneca’s ADC scientific platform. _Enhertu_
consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload,
an exatecan derivative, via a stable tetrapeptide-based cleavable linker.

_Enhertu_ (5.4 mg/kg) is approved in Canada, Israel and the US for the treatment
of adult patients with unresectable or metastatic HER2-positive breast cancer who
have received a prior anti-HER2-based regimen either in the metastatic setting, 
or in the neoadjuvant or adjuvant setting and have developed disease recurrence 
during or within six months of completing therapy, based on results from the DESTINY-
Breast03 trial.

_Enhertu_ (5.4mg/kg) is also approved in approximately 40 countries 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 based on the results from
the DESTINY-Breast01 trial.

_Enhertu_ (6.4mg/kg) is approved in several countries for the treatment of adult
patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal
junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen
based on the results from the DESTINY-Gastric01 trial.

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