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(Sharecast News) - AstraZeneca 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-nave 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
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