NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Thursday recommended approval for AstraZeneca and Daiichi Sankyo's TROP2-directed antibody drug conjugate Datroway (datopotamab deruxtecan) for patients with previously treated unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer.
The recommendation is specifically for patients who have previously received endocrine therapy and at least one line of chemotherapy in the advanced setting. The decision was based on results from the Phase III TROPION-Breast01 trial, in which Datroway demonstrated a 37 percent reduction in the risk of progression or death compared to investigator’s choice of chemotherapy. In the trial, median progression-free survival on Datroway was 6.9 months versus 4.9 months on chemo. Just over one-third, 36 percent, of patients on Datroway responded to treatment compared to 23 percent on chemo, and the median duration of response was 6.7 months and 5.7 months, respectively.
The CHMP's recommendation will now be reviewed by the European Commission, which has the authority to grant marketing authorizations for medicines in the EU.
Datroway was approved in the US earlier this month for treating HR-positive, HER2-negative unresectable or metastatic breast cancer patients who had prior endocrine therapy and chemotherapy.