Cambridge: AstraZeneca has announced that Datroway (datopotamab deruxtecan or Dato-DXd) has received accelerated approval ...

The FDA approval of Datroway is based on the results of the TROPION-Breast01 study, which showed that patients treated with the ADC had a median progression-free survival (PFS) of 6.9 months ...

The guidance is out for comment until 26th September and, if adopted, will replace earlier guidance on DAPs published by the FDA in 2022. Once finalised, trial sponsors will have 180 days to come ...