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The approval was based on positive results from a single-arm Phase II trial where the treatment demonstrated significant antitumor activities in patients with the disease.
AstraZeneca and Daiichi Sankyo announced on Jan. 20, 2021 that their HER2-positive metastatic breast cancer treatment, Enhertu (trastuzumab deruxtecan), has been granted conditional approval from the European Commission as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more previous anti-HER2-based regimens.
The approval was based on positive results from a single-arm Phase II trial where the treatment demonstrated significant antitumor activities in patients with the disease, AstraZeneca said in a company press release. The treatment was previously approved for use in the United States under accelerated approval, and in Japan under a conditional early approval system.
“Enhertu is already transforming outcomes for patients with HER2-positive metastatic breast cancer in the US and Japan, and this approval enables us to bring the benefits of this medicine to patients in the [European Union],” said Dave Fredrickson, executive vice president, Oncology Business Unit, AstraZeneca. “We will continue to explore the potential of Enhertu in this setting, as well as in earlier lines of treatment and stages of disease, with the ambition of improving the lives of patients with HER2-targetable breast cancer.”
“This expedited review underscores the practice-changing potential of Enhertu for patients in the metastatic setting,” added Gilles Gallant, senior vice president, global head, Oncology Development, Oncology R&D, Daiichi Sankyo, in the press release. “Enhertu is the first-ever new medicine to be approved in breast cancer in Europe on the basis of Phase II single-arm data, and one of the fastest accelerated assessment procedures for an application in oncology.”