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AstraZeneca: priority review granted for Enhertu

( - AstraZeneca and Daiichi Sankyo announce that they have applied to the US FDA for a supplemental biologics license for Enhertu (trastuzumab deruxtecan) for the treatment of adult patients in the US with unresectable or metastatic HER2-positive breast cancer who have received prior anti-HER2 background therapy.

The laboratories state that the application has been accepted for priority review, a status granted to applications that have the potential to offer significant improvements over available options.

The FDA's decision is expected in Q2 2022.

Jointly developed by AstraZeneca and Daiichi Sankyo, Enhertu is a combination antibody and drug (ADC) targeting HER2.

Breast cancer is the most common cancer in the world, with more than two million cases diagnosed in 2020, resulting in nearly 685,000 deaths worldwide.

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