(CercleFinance.com) – AstraZeneca and Daiichi Sankyo announce that they have applied to the United States Food and Drug Administration (FDA) to obtain an additional biological product license for Enhertu (trastuzumab deruxtecan) for the treatment of adult patients in United States with unresectable or metastatic HER2-positive breast cancer who have previously received anti-HER2 background therapy.
The labs say 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 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 almost 685,000 deaths worldwide.
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