The BLA submission is based on P-I study and the pivotal P-II DESTINY-Breast01 study. The P-II DESTINY-Breast01 study assessing Trastuzumab deruxtecan in 253 patients with HER2+ unresectable/metastatic breast cancer prior treated with Trastuzumab Emtansine
The US FDA has granted Priority Review to Trastuzumab deruxtecan to treat patients with HER2+ mBC with its expected PDUFA date in Q2’20
Trastuzumab Deruxtecan is an ADC- delivers cytotoxic agents to the targeted cancer cell via linker attached to a mAb- currently evaluating in 5 trials for multiple cancer and has received FDA’s BT- FT & MHLW’s Sakigake designation for HER2+ LA/m-breast cancer & advanced HER2+ gastric cancer respectively
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Ref: AstraZeneca | Image: AstraZeneca
