AstraZeneca (AZN) said Monday that the biologics license application for its experimental therapy, datopotamab deruxtecan, to treat a type of non-small cell lung cancer has been accepted and granted priority review in the US.
The Food and Drug Administration is expected to make decisions regarding the therapy in Q3, the company said.
The drugmaker said its application was based on data from the phase II trial and supported by the phase III trial of datopotamab deruxtecan that demonstrated an objective response rate of 42.7% and a median duration of response of 7 months.
Datopotamab deruxtecan is jointly developed by AstraZeneca and Daiichi Sankyo.
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