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FDA grants Enhertu Breakthrough Therapy Designation in breast cancer

Phase 3 trial data presented at ESMO shows Enhertu significantly reduced the risk of disease progression or death


The Food and Drug Administration (FDA) has granted Enhertu (trastuzumab deruxtecan) Breakthrough Therapy Designation (BTD) in the US 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.

The FDA granted BTD based on data from the DESTINY-Breast03 phase 3 trial presented during the European Society for Medical Oncology (ESMO) Congress 2021. The results of the phase 3 trial showed that Enhertu reduced the risk of disease progression or death by 72% vs trastuzumab emtansine (T-DM1). Nearly all patients treated with Enhertu were alive at one year (94.1%) compared to 85.9% of patients treated with T-DM1.

Enhertu is a HER2-directed antibody drug conjugate (ADC) jointly developed by AstraZeneca and Daiichi Sankyo that has now been granted four Breakthrough Therapy Designations, including two in breast cancer

A breakthrough therapy designation is given to accelerate the development and regulatory review of potential new medicines for serious condition that address a significant unmet medical need.

Breast cancer remains the most common cancer worldwide, with more than two million cases diagnosed in 2020, resulting in nearly 685,000 deaths globally. Approximately one in five cases of breast cancer are considered HER2-positive.

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “This is an important step in bringing Enhertu as a potential new option in earlier lines of treatment for HER2-positive metastatic breast cancer, given the urgent need to improve outcomes.

“This recognition by the FDA underscores the transformative possibility of Enhertu seen with the remarkable DESTINY-Breast03 results presented at ESMO just two weeks ago,” she added.

Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: “By granting a fourth Breakthrough Therapy Designation to Enhertu, the FDA continues to recognise the significant potential of this medicine across multiple HER2-targetable tumours.

“With the unprecedented data recently reported from the DESTINY-Breast03 trial, we look forward to working closely with the FDA to bring Enhertu to patients who have been previously treated for HER2-positive metastatic breast cancer as soon as possible,” he added.

Article by
Iona Everson

4th October 2021

From: Research, Regulatory



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