According to the financial app, on October 2, Daiichi Sankyo and AstraZeneca jointly announced that their jointly developed blockbuster antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has been accepted by the US FDA for supplemental biological product license application (sBLA) and granted priority review qualification. It is intended for the treatment of inoperable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-very low (IHC 0 with a membrane stain) expressing breast cancer adult patients who have received at least one line of metastatic endocrine therapy. The US FDA is expected to complete the review in the first quarter of 2025.

According to the press release, if approved, Enhertu will become the first HER2-targeted ADC therapy used before chemotherapy for metastatic breast cancer patients.

Breast cancer is one of the most common cancers and one of the leading causes of cancer-related deaths globally. HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of tumor cells, including various types of tumors such as breast cancer. It is estimated that approximately 60% to 65% of HR-positive, HER2-negative breast cancers are HER2-low expressing, while an additional 25% may be HER2-very low expressing tumors. Currently, there are no targeted therapies approved specifically for patients with HER2-very low expression.

Enhertu is an ADC therapy jointly developed by AstraZeneca and Daiichi Sankyo. Previous press releases indicated that Enhertu is the first HER2-targeted ADC therapy with indication for multiple cancer types.