AstraZeneca (AZN) and Daiichi Sankyo said Friday that the US Food and Drug Administration has approved Datroway for first-line treatment of adults with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy.
The approval followed the FDA's priority review based on phase 3 data showing Datroway, or datopotamab deruxtecan, improved median overall survival to 23.7 months compared with 18.7 months for patients treated with chemotherapy, the companies said.
Datroway also reduced the risk of disease progression or death by 43%, with median progression-free survival of 10.8 months versus 5.6 months for chemotherapy, according to the companies.
The safety profile of Datroway was evaluated in 319 patients, with serious adverse reactions including pneumonia, vomiting, COVID-19 and anemia reported in more than 1% of patients, while one fatality was linked to interstitial lung disease or pneumonitis, Daiichi Sankyo said.
Datroway is a TROP2-directed antibody drug conjugate discovered by Daiichi Sankyo and jointly developed and commercialized with AstraZeneca.
Shares of AstraZeneca were down 1.4% in Friday trading.
Price: $187.16, Change: $-2.59, Percent Change: -1.36%