(Alliance News) - The US drug regulator has approved Enhertu for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer, makers AstraZeneca PLC and Daiichi Sankyo Co Ltd said late Friday.
The US Food & Drug Administration approved the breast cancer indication for Enhertu under accelerated approval, based on tumour response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial, the two companies said.
"Enhertu has shown impressive results in women with HER2-positive metastatic breast cancer, with the majority of women benefiting from treatment and the median duration of the response exceeding 14 months," said Jose Baselga, executive vice president for Oncology R&D at AstraZeneca. "With this first approval, we are proud to bring Enhertu to patients with high unmet need, and we look forward to further exploring its potential in additional settings."
The pair said a regulatory submission for the treatment has been made in Japan as well. They said they are exploring the further potential of Enhertu in HER2-breast cancer with three ongoing Phase III trials.
Following US approval, AstraZeneca is due to pay partner Daiichi Sankyo USD125 million as a first milestone payment. The UK company said this will be capitalised together with the upfront payment made earlier in the year.
By Tom Waite; thomaslwaite@alliancenews.com
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