AstraZeneca (AZN) said its Datroway drug received accelerated US approval to treat adults with locally advanced or metastatic non-small cell lung cancer harboring epidermal growth factor receptor mutations, following prior EGFR-directed therapy and platinum-based chemotherapy.
The approval follows the Food and Drug Administration's priority review and breakthrough therapy designation, based on phase 2 and 3 data showing a 45% objective response rate and a median duration of response of 6.5 months, the company said Monday in a statement.
Datroway is being developed and commercialized by Daiichi Sankyo and AstraZeneca.
AstraZeneca owes $45 million to Daiichi Sankyo as a milestone payment following the US approval.