Datroway approved in EU for breast cancer treatment

• The European Union approved Datroway for first-line treatment of certain metastatic triple negative breast cancer patients.
• The approval was based on phase 3 trial results showing improvements in overall survival and progression-free survival.
• Daiichi Sankyo and AstraZeneca are expanding Datroway’s availability after previous approvals in other markets.

Datroway (datopotamab deruxtecan), developed by Daiichi Sankyo and AstraZeneca (NYSE:AZN), received European Union approval as a monotherapy treatment for adults with unresectable or metastatic triple negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy.

The European Commission approval followed positive results from the phase 3 TROPION-Breast02 trial, where Datroway demonstrated improvements in overall survival and progression-free survival compared with investigator’s choice of chemotherapy.

“‘With this approval, Datroway is the only TROP2 directed antibody drug conjugate approved in the EU that has demonstrated an overall survival benefit in the first-line setting,’” said Daiichi Sankyo, Inc. Global Head of Oncology Business and President and CEO Ken Keller.

In the TROPION-Breast02 trial, median overall survival was 23.7 months for patients treated with Datroway compared with 18.7 months for chemotherapy, while median progression-free survival was 10.8 months versus 5.6 months.

Datroway is now approved for two breast cancer indications in the European Union.

The trial showed Datroway reduced the risk of disease progression or death by 43% compared with chemotherapy, with an objective response rate of 62.5% compared with 29.3%.

The safety profile was evaluated in 319 patients receiving Datroway, with serious adverse reactions occurring in 17% of patients, including reports of pneumonia, vomiting, COVID-19, anemia and one fatal case attributed to interstitial lung disease or pneumonitis.