Biopharmaceutical company AstraZeneca PLC ((LSE: AZN) (STO: AZN) (Nasdaq: AZN)) announced on Monday that it has received US Food and Drug Administration (FDA) approval for Datroway (datopotamab deruxtecan, Dato-DXd) to treat adults with previously treated metastatic hormone receptor (HR)-positive, HER2-negative breast cancer. This approval is based on results from the TROPION-Breast01 Phase III trial, which showed a 37% reduction in the risk of disease progression or death compared to chemotherapy.

In the trial, patients treated with Datroway experienced a median progression-free survival (PFS) of 6.9 months, compared to 4.9 months for those receiving chemotherapy. Safety data indicated no new concerns, with interstitial lung disease (ILD) occurring in 4.2% of Datroway-treated patients, predominantly at low grades.

Datroway, developed by Daiichi Sankyo and jointly commercialised by AstraZeneca and Daiichi Sankyo, is a TROP2-directed antibody-drug conjugate (ADC). The treatment has already been approved in Japan and the US, with additional regulatory reviews underway in the EU, China, and other regions.

This approval marks AstraZeneca's eighth new medicine out of the 20 the company aims to deliver by 2030. AstraZeneca and Daiichi Sankyo are also exploring Datroway's potential in other cancers, including non-small cell lung cancer and triple-negative breast cancer.

AstraZeneca's oncology portfolio continues to grow, with strategic collaborations and innovative treatments aimed at transforming breast cancer care.