FDA Grants BOND-003 Fast Track & Breakthrough Designations....for high-risk BCG- unresponsive NMIBC with CIS with or without papillary tumours based on the interim analysis of 66 patients.In a phase 3 trial.
https://www.urologytimes.com/view/fda-grants-cretostimogene-grenadenorepvec-breakthrough-and-fast-track-designations-for-nmibc 3 month CRR = 68.% (after 6 treatments)
6 month CRR = 64 % (after 9 treatments)
In comparison our interim data based on 47 patients:
3 month CRR = 64.% (after one single treatment)
6 month CRR = 60 % (after one single treatment)
The BOND-003 patients will receive 3 additional weekly treatments at months 6, 9, 12 & 18
The TLD1433 patients will receive 1 additional treatment at 6 months
Total BOND-003 treatments = 21
Total TLD1433 treatments = 2