Shots:

• The approval follows the P-II study which involves assessing of Trodelvy in 108 adults with TNBC who had previously received a median of three prior systemic therapies in the metastatic setting (range: 2-10)
• The study resulted in ORR 33.3%- mDOR 7.7 mos. Additionally- the P-III ASCENT study (N=500) is halted by the independent Data Safety Monitoring Committee (DSMC) for compelling evidence of efficacy across multiple endpoints with expected results in mid-2020
• TRODELVY (sacituzumab govitecan-hziy) is a novel ADC targeting the Trop-2 antigen approved by the US FDA for relapsed or refractory metastatic TNBC and is currently being evaluated as a treatment for eight hard-to-treat solid cancers

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