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EMA to Review Daiichi Sankyo, AstraZeneca's Enhertu For Second-Line HER2-Positive Breast Cancer

NEW YORK – Daiichi Sankyo said on Tuesday that the European Medicines Agency has validated its Type II Variation Application for trastuzumab deruxtecan (T-DXd; Enhertu) for the treatment of advanced, previously treated HER2-positive breast cancer patients.

With the application, Daiichi Sankyo and the drug's codeveloper, AstraZeneca are specifically seeking European approval for T-Dxd for unresectable or metastatic HER2-positive breast cancer patients who have received at least one prior anti-HER2 treatment.

Now, EMA's Committee for Medicinal Products for Human Use (CHMP) will begin scientifically reviewing the application, which includes data from the Phase III DESTINY-Breast03 trial. In that trial — for which interim results were presented at the European Society for Medical Oncology meeting this fall — T-DXd was pitted against Genentech's antibody-drug conjugate ado-trastuzumab emtansine (Kadcyla; T-DM1) for patients with HER2-positive advanced breast cancer treated with one prior anti-HER2 therapy.

After a year of follow-up, the progression-free survival rate among patients treated with T-DXd was 75.8 percent versus 34.1 percent among patients treated with T-DM1. Median progression-free survival was not yet reached as of the data cutoff for patients treated with T-DXd and 6.8 months for patients treated with T-DM1.

The agent has already been approved in multiple regions as a later-line treatment, for patients who have received two or more prior HER2-targeting therapies.

"With this specific application, we look forward to working closely with the EMA to support the review of trastuzumab deruxtecan to be used in an earlier setting for patients with HER2-positive metastatic breast cancer," Gilles Gallant, Daiichi Sankyo's global head of oncology development and R&D said in a statement.