Astrazeneca's Enhertu secures EU approval

(Sharecast News) - Drugmaker Astrazeneca said on Tuesday that Enhertu has been approved in the European Union as an adjuvant treatment for adults with HER2positive early breast cancer who still have signs of invasive disease after initial chemotherapy and targeted therapy.

Astrazeneca said the approval marks the drug's first EU approval in an earlystage, curativeintent setting and follows a decision from the European Commission based on the large DESTINYBreast05 Phase III trial, which showed Enhertu cut the risk of the cancer returning or causing death by 53% compared with the current standard treatment, TDM1.

In the study, 92.4% of patients on Enhertu were alive and free of invasive disease three years after treatment, versus 83.7% for those given TDM1.

Clinicians involved in the trial said reducing the chance of recurrence is crucial for patients who still have residual disease after their first round of therapy, and that the results suggested Enhertu could reshape treatment for this group.

Daiichi Sankyo, Astrazeneca's partner on the drug, said moving Enhertu into earlier lines of treatment could help improve longterm outcomes. The companies said the safety profile was in line with previous studies, with no new concerns identified.

Enhertu now has approval in more than 35 countries for use after neoadjuvant therapy in HER2positive early breast cancer.

Following the EU approval, Astrazeneca will pay Daiichi Sankyo $75m as a milestone payment for the adjuvant HER2-positive early breast cancer indication. Sales of Enhertu in most EU territories will be recognised by Daiichi Sankyo.

As of 1120 GMT, Astrazeneca shares were down 0.016% at 12,852p.

Reporting by Iain Gilbert at Sharecast.com

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