(Sharecast News) – Drug companies AstraZeneca and Daiichi Sankyo said their Enhurtu breast cancer drug had won conditional approval in the European Union.
The duo said on Wednesday that the drug was granted approval as a monotherapy for the treatment of adult patients with HER2-positive breast cancer who had received two or more prior anti-HER2-based regimens.
HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours, including breast cancer, AstraZeneca said in a statement.
“Overexpression of the protein may be associated with a specific HER2 gene alteration known as HER2 amplification and is often associated with aggressive disease and a poor prognosis in breast cancer,” the company added.
“There remain significant unmet clinical needs for patients with HER2-positive metastatic breast cancer. The disease remains incurable with patients eventually progressing after currently available treatment options.”
In Europe, around 531,000 cases of breast cancer in women are diagnosed annually, with an estimated one in five cases being HER2-positive. The impact of the disease is significant, with breast cancer responsible for more than 141,000 deaths per year in Europe.
Approval for the drug was based on positive results from its phase 2 trial, in which Enhertu showed “clinically meaningful and durable antitumour activity in patients with HER2-positive metastatic breast cancer”.
Following EU approval, $75m is due from AstraZeneca to Daiichi Sankyo as a milestone payment.
