07:47 AM EST, 12/09/2024 (MT Newswires) -- Astrazeneca ( AZN ) said Monday that the US Food and Drug Administration has granted breakthrough therapy designation for datopotamab deruxtecan for the treatment of locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer in adult patients.
The company said the designation is intended to expedite the development and regulatory review of potential new therapies that can treat serious conditions and address unmet medical needs.
Astrazeneca ( AZN ) said the designation was based on data from phase 2 trial, with supporting data from a phase 3 trial.
Datopotamab deruxtecan is being jointly developed by AstraZeneca ( AZN ) and Daiichi Sankyo, according to the statement.