AstraZeneca's Enhertu gets further EU approval
and Daiichi Sankyo's Enhertu has been approved in the European Union as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer, the companies said on Friday.
The treatment is for patients who have received at least one hormone therapy and who are not considered suitable for the same approach as the next line of treatment, they added.
The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the DESTINY-Breast06 Phase III trial.
In the trial, Enhertu showed a 38% reduction in the risk of disease progression or death versus chemotherapy in patients with chemotherapy-naïve HR-positive, HER2-low metastatic breast cancer with a median progression-free survival (PFS) of 13.2 months versus 8.1 months.
Enhertu was approved in the US earlier this year based on the Destiny-Breast06 results. Regulatory applications are under review in Japan and several other countries for this indication, the companies said.
Reporting by Frank Prenesti for Sharecast.com
Disclaimer & Declaration of Interest
The information, investment views and recommendations in this article are provided for general information purposes only. Nothing in this article should be construed as a solicitation to buy or sell any financial product relating to any companies under discussion or to engage in or refrain from doing so or engaging in any other transaction. Any opinions or comments are made to the best of the knowledge and belief of the writer but no responsibility is accepted for actions based on such opinions or comments. Vox Markets may receive payment from companies mentioned for enhanced profiling or publication presence. The writer may or may not hold investments in the companies under discussion.