FDA GRANTS FAST TRACK DESIGNATION TO SACITUZUMAB GOVITECAN FOR NEOADJUVANT/ADJUVANT METASTATIC UROTHELIAL CANCER
IMMUNOMEDICS (IMMU)
Last immunomedics earnings: 2/27 04:00 pm
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US:NASDAQ Investor Relations:
immunomedics.com/2017/immunomedics-announces-presentations-investor-event-2017-san-antonio-breast-cancer-symposium
Company Research
Source: GlobeNewswire
MORRIS PLAINS, N.J., April 07, 2020 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for sacituzumab govitecan for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting, including patients who are platinum ineligible and have previously received a PD-1 or PD-L1 inhibitor in the neoadjuvant/adjuvant, locally advanced, or metastatic setting. “Coming in the wake of a recent unanimous recommendation by the independent Data Safety Monitoring Committee for the ASCENT study to stop the trial due to compelling evidence of
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