AstraZeneca's Enhertu gets new US approval
By Frank Prenesti
Date: Thursday 30 Jan 2025
(Sharecast News) - AstraZeneca and Daiichi Sankyo's Enhertu has been approved in the US for the treatment of adults with HER2 breast cancer, after disease progression having had one or more hormone therapies.
The approval was granted by the Food and Drug Administration based on results from the DESTINY-Breast06 phase 3 trial, which were presented at the 2024 American Society of Clinical Oncology meeting and published in The New England Journal of Medicine, the companies said on Tuesday.
In the trial, Enhertu showed a 36% reduction in the risk of disease progression or death, compared to chemotherapy, in the overall trial population of patients with chemotherapy-naïve HER2-low or HER2-ultralow metastatic breast cancer.
Hormone, or endocrine, therapies are widely given consecutively in the early lines of treatment for HR-positive metastatic breast cancer. However, after initial treatment, further efficacy from endocrine therapy is often limited. The current standard of care following endocrine therapy is chemotherapy, which is associated with poor response rates and outcomes.
AstraZeneca will now pay $175m to Daiichi Sankyo for reaching the HER2-low and HER2-ultralow chemotherapy-naïve breast cancer indication milestone.
Reporting by Frank Prenesti for Sharecast.com
Email this article to a friend
or share it with one of these popular networks:
You are here: news
10 Lower Thames St,
London EC3R 6EN