EMA validates and grants accelerated assessment for trastuzumab deruxtecan for the treatment of HER2 positive metastatic breast cancer

Daiichi Sankyo

6 July 2020 - Daiichi Sankyo today announced that the EMA has validated the marketing authorisation application for trastuzumab deruxtecan, a HER2 directed antibody drug conjugate, for the treatment of adults with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens. 

Trastuzumab deruxtecan was granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use.

The application 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.

Read Daiichi Sankyo press release 

Michael Wonder

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Michael Wonder