Partners AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) have been granted an additional indication by the US Food and Drug Administration (FDA) for their antibody drug conjugate (ADC) Enhertu (trastuzumab deruxtecan). The new indication authorizes the use of Enhertu as a treatment for unresectable or metastatic HER2-positive solid tumors in adults who have received prior systemic treatment and have no alternative treatment options. This milestone makes Enhertu the first tumor-agnostic HER2-directed cancer therapy approved in the United States.
The accelerated approval was supported by data from three Phase II studies that demonstrated Enhertu’s clinically meaningful efficacy, as evidenced by objective response rate (ORR) and duration of response (DoR), across various types of HER2-positive metastatic cancers. The safety profile of the drug remained consistent with previous trial observations.
Enhertu’s original US approvals included indications for specific cancer sites, such as breast cancer, non-small cell lung cancer (NSCLC), and gastric or gastroesophageal junction (GEJ) adenocarcinoma. This new indication significantly broadens the patient population that may benefit from Enhertu’s targeted approach to treating HER2-positive cancers.- Flcube.com
