EU Recommends HER2-Positive Metastatic Breast Cancer Treatment
AstraZeneca and Daiichi Sankyo's trastuzumab deruxtecan has been recommended for conditional marketing authorization in the European Union as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens.
Trastuzumab deruxtecan is approved under the brand name Enhertu (5.4mg/kg) in the US and Japan for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting based on the DESTINY-Breast01 trial. In September 2020, Enhertu (6.4mg/kg) was approved in Japan for patients with HER2-positive unresectable advanced or recurrent gastric cancer that progressed after chemotherapy based on the DESTINY-Gastric01 trial.
José Baselga, AstraZeneca's EVP, Oncology R&D, said in a press release issued on December 14, 2020: “The durable responses demonstrated in the DESTINY-Breast01 trial have never been seen before in this patient setting. If approved by the European Commission, physicians in Europe will have an important new treatment option for patients with previously treated HER2-positive metastatic breast cancer.”
HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors, including breast, gastric, lung, and colorectal cancers, said the company.