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FDA Grants Fast Track, Breakthrough Therapy Designations to Cretostimogene Grenadenorepvec for NMIBC

The FDA has granted fast track and breakthrough therapy designations to cretostimogene grenadenorepvec for use as a potential therapeutic option in patients with high-risk BCG-unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without Ta or T1 tumors.

United statesAmbaw belleteCg oncology incAmerican urological association annual meetingMeeting of the society urological oncologyBacillus calmette guAnnual meetingUrological association annual meetingAccessed januaryFast track and breakthrough therapy designationsCretostimogene grenadenorepvecPatients with high risk bcg unresponsive non muscle invasive bladder cancer carcinoma in situ or without ta t1 tumorsBond 003 study

CG Oncology Receives Both FDA Fast Track and Breakthrough Therapy Designation for Cretostimogene Grenadenorepvec in High-Risk BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

CG Oncology Receives Both FDA Fast Track and Breakthrough Therapy Designation for Cretostimogene Grenadenorepvec in High-Risk BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
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United statesCretostimogene grenadenorepvecAndrea maddox smithBing kungAmbaw belleteDrug administrationCg oncology incCalif business wire cg oncology incBladder cancer advocacy networkCorporate developmentMeeting of the society urological oncologyBoth fast trackBreakthrough therapy designationFast track designationBacillus calmette guNon muscle invasive bladder cancer

CG Oncology Receives Both FDA Fast Track and Breakthrough Therapy Designation for Cretostimogene Grenadenorepvec in High-Risk BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

CG Oncology Receives Both FDA Fast Track and Breakthrough Therapy Designation for Cretostimogene Grenadenorepvec in High-Risk BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
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United statesCretostimogene grenadenorepvecBing kungAndrea maddox smithAmbaw belleteCg oncology incCorporate developmentMeeting of the society urological oncologyBladder cancer advocacy networkDrug administrationFast track designationBreakthrough therapy designationBacillus calmette guNon muscle invasive bladder cancerChief operating officerChief executive officer

Cretostimogene Grenadenorepvec Confers High CR Rate in NMIBC

Preliminary findings from the phase 3 BOND-003 trial showed that treatment with cretostimogene grenadenorepvec led to sustained and durable complete responses and a tolerable safety profile in patients with high-risk non-muscle invasive bladder cancer who are unresponsive to Bacillus Calmette-Guerin.

United statesUniversity of pennsylvaniaArthur kuanTrinityj bivalacquaPerelman centerAmerican urological associationMedicine of the university pennsylvaniaMeeting of the society urological oncologyBacillus calmette guerinAnnual meetingUrological oncologyAdvanced medicinePhase 3 bond 003Cretostimogene grenadenorepvecSociety of urological oncology