Enhertu receives priority review as post-neoadjuvant treatment for patients with HER2-positive early breast cancer

AstraZeneca and Daiichi Sankyo’s sBLA for Enhertu has been accepted and granted Priority Review in the US for the treatment of adult patients with HER2-positive breast cancer who have residual invasive disease after neoadjuvant HER2-targeted treatment.

The FDA recently granted Enhertu Breakthrough Therapy Designation in this setting. BTD accelerates the development and regulatory review of potential new medicines intended to treat a serious condition and address a significant unmet medical need.

Note that the sBLA also is being reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners.

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “While there has been significant progress in treating HER2-positive early breast cancer, managing patients at a higher risk of recurrence remains challenging. With this Priority Review, we move closer to bringing Enhertu to the post-neoadjuvant setting, offering more patients the opportunity for sustained long-term outcomes and a potential path to cure.”

Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: “For patients with residual invasive disease after neoadjuvant therapy, identifying additional treatments following surgery is critical to help further reduce the risk of recurrence and help prevent progression to metastatic disease. This Priority Review reinforces the potential of Enhertu to become a new standard of care for HER2-positive early breast cancer based on the results of DESTINY-Breast05.”

Enhertu significantly reduced the risk of invasive disease recurrence or death by 53% compared with trastuzumab emtansine as a post-neoadjuvant treatment for patients with HER2-positive breast cancer. Enhertu demonstrated a three-year IDFS rate of 92.4% compared with 83.7% with T-DM1. IDFS findings were consistent across all prespecified subgroups.

The safety profile of Enhertu observed in DESTINY-Breast05 was consistent with its known profile with no new safety concerns identified.

In addition, the regulatory submissions for Enhertu based upon DESTINY-Breast05 are also under review in the EU and Japan. In addition, an sBLA for Enhertu followed by paclitaxel, trastuzumab and pertuzumab currently is under review in the US for the neoadjuvant treatment of patients with HER2-positive early breast cancer based on results from the DESTINY-Breast11 trial.

 

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Related Topics and Keywords

breast cancer, enhertu, ER+/HER2- Advanced Breast Cancer