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AstraZeneca: Enhertu Gets Priority Review In The US

AstraZeneca and Daiichi Sankyo said the supplemental Biologics License Application of Enhertu have been granted priority review for the treatment of adult patients in the US with unresectable or metastatic HER2-low breast cancer who have received a prior therapy in the metastatic setting. The FDA action date for the regulatory decision is during the fourth quarter of 2022.

The companies noted that the Priority Review follows receipt of Breakthrough Therapy Designation in the US in April 2022 in metastatic HER2-low breast cancer.

Enhertu is being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

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