Enhertu Receives Two Additional FDA Breakthrough Therapy Designations for HER2-Positive Solid Tumors and Metastatic Colorectal Cancer

Intelligent Finance APP learned on September 1 that AstraZeneca (AZN.US) and Daiichi Sankyo announced that their antibody-drug conjugate (ADC) Enhertu has been granted two Breakthrough Therapy Designations (BTD) by the U.S. FDA for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumors who have progressed after prior treatment and have no alternative treatment options, as well as for the treatment of HER2-positive (IHC 3+) metastatic colorectal cancer patients who have received two or more prior treatment regimens. It is reported that Enhertu has been granted a total of seven Breakthrough Therapy Designations.

Data shows that Enhertu is an ADC therapy jointly developed by AstraZeneca and Daiichi Sankyo. It is designed using Daiichi Sankyo's proprietary DXd ADC technology platform, consisting of a humanized monoclonal antibody targeting HER2 linked to a topoisomerase 1 inhibitor payload through a cleavable tetrapeptide linker.