FDA accepts sacituzumab govitecan application for listing of biological products for triple-negative breast cancer treatment

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Pharmaceuticals(The Companythat the U.SFDA(govitecan, which has accepted itsdrug( and has been treated at least twice in the past for metastatic triple-negative breast cancer (mTNBC) for biological products to be marketed (BLA) and given priority review seeking a review of the applicationPDUFA application is set for January 18, 2019this BLA application is based on clinical 1/2 study data from sacituzumab govitecanFrom July 2013 to February 2017, a total of 110 mTNBC members from the study group who had received treatment above 2 linesPatients receive sacituzumab govitecan (IMMU-132) 10 mg/kg, 1st, 8th day, 21 days of 1 cycle of treatment, until there is a progression of the disease or intolerable adverse reactionsData deadlines of June 30, 2017results show that the objective mitigation rate (ORR) was 34% (37/110), of which 3 were full remission (CR) and 34 were partial lysing (PR)The clinical benefit rate (CBR: CR-PR-SD for 6 months) was 46%Median continuous reaction time (DOR) was 7.6 months, median progression less than time (PFS) was 5.5 months, and median total survival time (OS) was 12.7 monthsOf these, 11 patients had longer PFS periods, from December to 30 monthsSacituzumab govitecan single drug can effectively treat after severe treatment (3 lines above) relapse or difficult to treat mTNBCSacituzumab govitecanSacituzumab govitecan is the most advanced candidateproduct of Theof The Best of The of Immunomedics( a novel global first-in-class ADC drug consisting of anti-TROP-2 monoantigen and cytotoxic SN-38