FDA Accepts BLA for Dato-DXd in Previously Treated HR-Positive, HER2-Negative Metastatic Breast Cancer

AstraZenecaand Daiichi Sankyo jointly announced，TargetedTrop2OfADCCandidate Productdatopotamab deruxtecan（Dato-DXd) Biologics License Application (BLA) has been approved in the United StatesFDAAcceptance, for the treatment of unresectable or metastatic hormone receptor (HR) Positive,HER2Negative (IHC 0、IHC 1+OrIHC 2+/ISH-) Adult patients with breast cancer, PDUFA target action date is the first quarter of 2025.

It is worth mentioning that,Dato-DXd for the treatment ofLocally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer Previously Treated with Systemic Therapy（NSCLC）Adult PatientsBLAAlready received FDA acceptance in February this year，PDUFA Date: 2024On December 20, if successfully approvedWill become the first TROP2-targeted ADC drug for the treatment of lung cancer patients。

Dato-DXd is an ADC composed of a humanized, Trop2-targeted monoclonal antibody linked to the innovative DNA topoisomerase I inhibitor (DXd). Compared with traditional chemotherapy drugs, DXd exhibits 10 times higher activity and has a strong ability to penetrate cell membranes, enabling it to generate"Bystander Effect"。

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It is reported that this BLA is based on the results of the pivotal TROPION-Breast01 Phase III trial, which showed that, compared to investigator-selected chemotherapy, Dato-DXd demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who had previously received systemic therapy; an improvement trend in overall survival (OS) was also observed.

Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, stated: "Despite significant advances in the treatment of HR-positive, HER2-negative breast cancer, most patients with advanced disease develop resistance to endocrine therapy. If Dato-DXd is approved, it has the potential to offer these patients an effective and better-tolerated alternative."

Ken Takeshita, Global R&D Head of Daiichi Sankyo, stated: "The FDA's acceptance of the BLA brings us closer to providing a new treatment option for these patients, and we are making progress in multiple regions to bring this candidate product to patients worldwide."