Astra and Daiichi finally get their Datroway

After a bumpy ride, AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan has finally crossed the FDA finish line. The anti-TROP2 ADC, branded Datroway, was approved on Friday for second-line ER-positive, HER2-negative breast cancer – despite the phase 3 Tropion-Breast01 study only showing a statistically significant benefit on PFS, but not OS. Still, FDA approval had been expected after a recent green light in Japan. Datroway’s US label has a warning for interstitial lung disease – again not surprising, as this is a known side effect of the ADC. Tropion-Breast01 had a 4.2% rate of ILD; while most events were low grade, there was one fatal ILD case. In the more important lung cancer setting, the partners recently pulled a second-line non-squamous NSCLC filing to focus on EGFRm disease, where a new PDUFA date of 12 July has just been announced. The companies are also targeting the bigger use of first-line NSCLC and a key readout here will come this year from the Avanzar trial, primarily analysing TROP2-positive patients. However, readout of Tropion-Breast02, in first-line triple-negative breast cancer, has been delayed from 2024 into 2025. There’s also been no sign of data from Gilead’s analogous Ascent-03 trial of Trodelvy.

Datroway phase 3 breast cancer trials

Source: OncologyPipeline & clinicaltrials.gov.