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Immunomedics' Trodelvy Receives the US FDA's Accelerated Approval for 2L Patients with Metastatic Triple-Negative Breast Cancer (TNBC)

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Immunomedics' Trodelvy Receives the US FDA's Accelerated Approval for 2L Patients with Metastatic Triple-Negative Breast Cancer (TNBC)

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

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


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