FDA Has Granted Enhertu Breakthrough Therapy Designation (BTD) for Adult Patients with Unresectable/Metastatic HER2 +Ve Breast Cancer

The Food and Drug Administration has granted Enhertu (trastuzumab deruxtecan) Breakthrough Therapy Designation (BTD) in the US to treat adult patients with unresectable or metastatic HER2 +Ve breast cancer who have previously received single or multiple anti-HER2-based regimens.

Enhertu is a HER2-directed ADC (antibody-drug conjugate) jointly developed by AstraZeneca and Daiichi Sankyo Company, Ltd (hereafter, Daiichi Sankyo).

The Food and Drug Administration granted the designation based on data from the Phase III trial named DESTINY-Breast03, presented during the European Society for Medical Oncology Congress 2021.

As per AstraZeneca’s press release, this is now the second Breakthrough Therapy Designation for trastuzumab deruxtecan in breast cancer, bringing its total number of Breakthrough Therapy Designations to four.

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, stated: “This is a crucial step in order to bring Enhertu as a potential new treatment option in earlier lines for HER2 +Ve metastatic breast cancer, given the urgent requirement to improve outcomes. This recognition by the FDA underscores the transformative possibility of Enhertu noted with the remarkable DESTINY-Breast03 outcomes presented at European Society for Medical Oncology just a couple of weeks ago.”

Ken Takeshita, Global Head, R&D, Daiichi Sankyo, stated: “By granting 4’th Breakthrough Therapy Designation (BTD) to Enhertu, the FDA continues to detect the significant potential of this drug across the multiple HER2-targetable tumours. Along with unprecedented findings recently considered from the trial named DESTINY-Breast03, we look forward to working precisely with the Food & Drug Administration in order to bring Enhertu to recipients who’ve been earlier treated for HER2 +Ve metastatic breast cancer as soon as possible.”

In the trial named DESTINY-Breast03, Enhertu (trastuzumab deruxtecan) demonstrated a 72 percent reduction in the probability of disease progression or death compared to T-DM1 in recipients with HER2 +Ve unresectable and/or metastatic breast cancer earlier treated with medication trastuzumab and a taxane.

The consistent safety profile was noted with previously held clinical trials, with no new safety concerns observed and no grade 4/5 treatment-related ILD events, as per the press release.

Enhertu (trastuzumab deruxtecan) is approved to treat adult patients with unresectable or metastatic HER2 +Ve breast cancer who have previously received double or multiple prior anti-HER2-based regimens in the metastatic setting in the US, Japan, the EU, and some of the other nations on behalf of findings from the trial named DESTINY-Breast01.

Enhertu (trastuzumab deruxtecan) is being further evaluated in a comprehensive clinical development program assessing efficacy as well as safety across multiple HER2-targetable cancers, including breast, lung, gastric and colorectal cancers.

Reference:

https://www.astrazeneca.com/media-centre/press-releases/2021/enhertu-granted-btd-for-breast-cancer.html