FDA grants BTD for Daiichi Sankyo and AstraZeneca’s Enhertu

pharmafile | October 4, 2021 | News story | Research and Development, Sales and Marketing  

AstraZeneca and Daiichi Sankyo have today announced that the FDA has granted Enhertu (fam-trastuzumab deruxtecan-nxki) breakthrough therapy designation (BTD) 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 Phase III DESTINY-Breast03 trial, wherein Enhertu demonstrated a 72% reduction in the risk of disease progression or death compared to T-DM1.

Enhertu is a HER2 directed antibody drug conjugate (ADC) jointly developed by AstraZeneca and Daiichi Sankyo.

Ken Takeshita, Global Head of R&D at 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.”

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.

Despite initial treatment with trastuzumab and a taxane, patients with HER2 positive metastatic breast cancer will often experience disease progression.

Susan Galbraith, Executive Vice President of Oncology R&D at 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.”

Enhertu (trastuzumab deruxtecan) is a HER2 directed ADC, that was designed using Daiichi Sankyo’s 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.

Currently, Enhertu is approved in Canada, the EU, Israel, Japan, UK, and US 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 in the metastatic setting based on the results from the DESTINY-Breast01 trial.

Kat Jenkins



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