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Today, AstraZeneca and Daiichi Sankyo jointly announced that the supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan), their jointly developed antibody drug conjugate (ADC), has been granted by the U.
Lung cancer is the second most common type of cancer worldwide, with more than 2 million newly diagnosed patients in 2020
Enhertu is an ADC therapy jointly developed by AstraZeneca and Daiichi Sankyo
This sBLA is based primarily on positive results from the registrational Phase 2 clinical trial DESTINY-Lung01
At a median follow-up of 13.
Dr Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "The DESTINY-Lung01 clinical trial validates HER2 gene mutation as a targetable biomarker in non-small cell lung cancer
References:
[1] Enhertu granted Priority Review in the US for patients with previously treated HER2-mutant metastatic non-small cell lung cancer.