AstraZeneca and Daiichi Report the US FDA’s Acceptance of BLA for Trastuzumab deruxtecan (DS-8201) and Granted Priority Review

AstraZeneca and Daiichi Report the US FDA's Acceptance of BLA for Trastuzumab deruxtecan (DS-8201) and Granted Priority Review

Shots:

  • 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

Click here to­ read full press release/ article | Ref: AstraZeneca | Image:  Pharmaphorum