Enhertu closer to US approval as earlier option for HER2-positive metastatic breast cancer

4 October 2021

The US Food and Drug Administration (FDA) has granted Enhertu (trastuzumab deruxtecan), Breakthrough Therapy designation (BTD) for unresectable or metastatic HER2-positive breast cancer patients who have received one or more prior anti-HER2-based regimens.

Enhertu is a HER2-directed antibody drug conjugate (ADC) jointly developed by Anglo-Swedish pharma major AstraZeneca (LSE: AZN) and Japanese drugmaker Daiichi Sankyo Company (TYO: 4568).

"The FDA continues to recognize the significant potential of this medicine across multiple HER2-targetable tumors"The FDA granted BTD based on data from the DESTINY-Breast03 Phase III trial presented during the European Society for Medical Oncology (ESMO) Congress 2021. This is the second BTD for Enhertu in breast cancer and now brings the total number of BTDs to four for this medicine.

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