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Immunomedics Reports the US FDA's Acceptance of BLA for Sacituzumab Govitecan to Treat Metastatic Triple-Negative Breast Cancer

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Immunomedics Reports the US FDA's Acceptance of BLA for Sacituzumab Govitecan to Treat Metastatic Triple-Negative Breast Cancer

Shots:

  • The US FDA has accepted resubmission of BLA- seeking accelerated approval of sacituzumab govitecan to treat patients with mTNBC- prior treated with at least two therapies for metastatic disease- as a complete class 2 response
  • The company is closely working with the US FDA to facilitate its review on BLA- which allow the company to bring potentially transformational therapy targeting unmet medical needs of mTNBC patients
  • Sacituzumab govitecan is a first-in-class ADC delivering SN-38 to tumor cells by targeting the Trop-2 antigen and has received FDA’s FT & BT designation with its expected PDUFA date as June 02- 2020

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


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