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

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