AstraZeneca: Enhertu approved in China
(CercleFinance.com) - AstraZeneca announces that its Enhertu (trastuzumab deruxtecan) has received conditional approval in China as monotherapy for the treatment of adult patients with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received at least two prior treatment regimens.
Conditional approval from the National Medical Products Administration (NMPA) was based on positive results from a Phase II trial.
Full approval for this indication will depend on the ability of a confirmatory randomized controlled trial to demonstrate clinical benefit in this population.
Enhertu is an antibody-drug conjugate (ADC) specifically designed for HER2, discovered by Daiichi Sankyo and jointly developed and marketed by AstraZeneca and Daiichi Sankyo.
Copyright (c) 2024 CercleFinance.com. All rights reserved.
Conditional approval from the National Medical Products Administration (NMPA) was based on positive results from a Phase II trial.
Full approval for this indication will depend on the ability of a confirmatory randomized controlled trial to demonstrate clinical benefit in this population.
Enhertu is an antibody-drug conjugate (ADC) specifically designed for HER2, discovered by Daiichi Sankyo and jointly developed and marketed by AstraZeneca and Daiichi Sankyo.
Copyright (c) 2024 CercleFinance.com. All rights reserved.