(CercleFinance.com) – AstraZeneca and Daiichi Sankyo announce that the United States Food & Drug Administration has received the Supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) for the treatment of adult patients in the United States with certain non-small cell lung cancers (NSCLC).
The FDA has also granted priority review status to this application, with Enhertu having already been qualified as a ‘breakthrough therapy’ in this type of cancer in May 2020.
As a reminder, Enhertu is an antibody-drug conjugate (ADC) jointly developed by AstraZeneca and Daiichi Sankyo.
‘If approved, Enhertu has the potential to become a new standard treatment providing a much-needed option for patients with metastatic HER2-mutated non-small cell lung cancer who currently have no targeted treatment options’ , explained in substance Susan Galbraith, executive vice-president in charge of R&D in oncology at AstraZeneca.
AstraZeneca adds that Enhertu is also undergoing further evaluation as part of a comprehensive clinical development program evaluating its efficacy in breast, stomach, lung and colorectal cancers in particular.
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