The Center for Drug Evaluation (CDE) website has indicated that Johnson & Johnson (J&J; NYSE: JNJ) has received two tacit clinical trial approvals for its Category 1 drug cetrelimab combined with TAR-200. The approvals are for the treatment of high-risk non-muscle-invasive bladder cancer (NMIBC) patients not receiving BCG treatment, and myometrial infiltrating bladder urothelial carcinoma patients who have not undergone total cystectomy.
Cetrelimab and TAR-200: A Promising Combination
Cetrelimab is a PD-1 monoclonal antibody (mAb) under development by J&J for the treatment of bladder cancer, melanoma, and multiple myeloma. It is administered intravenously and is part of a combination therapy approach. TAR-200 is an innovative bladder drug delivery system designed to release low-dose chemotherapy drug gemcitabine over an extended period.
Positive Results from Phase II Clinical Trial
The Phase II clinical trial of cetrelimab and TAR-200 in high-risk NMIBC patients who did not respond to BCG has reported positive efficacy and safety results. In the trial, the cetrelimab treatment group achieved a complete remission (CR) rate of 38.1%, while the TAR-200 treatment group reached a CR rate of 72.7%. The combination treatment group’s results are anticipated to be announced subsequently.
Future Outlook
These tacit approvals from the CDE underscore the potential of J&J’s cetrelimab and TAR-200 in addressing the unmet needs of high-risk bladder cancer patients. The combination therapy’s positive outcomes in the Phase II trial suggest a promising direction for future treatments, offering hope for improved patient outcomes in this challenging disease area.-Fineline Info & Tech
