How Johnson & Johnson’s bladder cancer drug works
In the United States, bladder cancer is the fifth most common cancer and in Italy cases are increasing among both women and men, who remain the most affected. Johnson & Johnson has received the green light for a drug aimed at the most serious cases. All the details
Johnson & Johnson announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to its Tar-200 drug for the treatment of patients with high-risk non-muscle invasive bladder cancer who do not respond to Bacillus immunotherapy. Calmette-Guérin (BCG).
This designation is intended to expedite the development and regulatory review of the drug because it is intended to treat a life-threatening condition.
NON-MUSCLE INVASIVE BLADDER CANCER
Non-muscle invasive bladder cancer, also more generally called bladder cancer, is a superficial tumor that does not develop into the deeper layers of the bladder wall, explains the Italian Society of Urology (SIU).
Based on their growth, there are three types. Stage Ta tumors are limited to the innermost wall of the bladder; stage T1 tumors are those that have already invaded the connective tissue under the internal lining wall of the bladder, but have not yet developed into the muscular portion of the bladder wall; and, finally, Cis, better known as carcinoma in situ, is a type of Tis stage tumor that is confined to the urothelium but with a high risk of spreading into the deeper layers of the bladder.
EXISTING TREATMENTS
Treatment options, explains the Urology Care Foundation , are cystoscopic resection (removal) of the tumor, Bacillus Calmette-Guérin (BCG) immunotherapy administered intravesically, and intravesical chemotherapy.
If these interventions are unsuccessful, your doctor may recommend a cystectomy, which is the partial or total removal of the bladder.
J&J'S DRUG
Johnson & Johnson's drug, TAR-200, is a new investigational system designed to provide sustained local release of gemcitabine in the bladder. It is intended for those patients who do not respond to Bacillus Calmette-Guérin (BCG) immunotherapy and are not eligible or have chosen not to undergo radical cystectomy.
“TAR-200 represents a new interventional approach for the treatment of localized bladder cancer, where today, unfortunately, options are limited and include antiquated BCG therapy or radical cystectomy,” said Kiran Patel, vice president of clinical development .
Currently, J&J reports , radical cystectomy is recommended for patients with non-muscle invasive bladder cancer who do not respond to BCG therapy, with over 90% cancer-specific survival if performed before muscle invasive progression.
STUDIES IN PROGRESS
The ongoing Phase 2b study is also evaluating the safety and efficacy of TAR-200 in combination with cetrelimab, TAR-200 alone or cetrelimab alone for patients with carcinoma in situ (CIS) unresponsive to BCG treatment, ineligible or who have decided not to undergo radical cystectomy.
Cetrelimab, which is administered intravenously, is an investigational monoclonal antibody designed to treat bladder cancer, prostate cancer, melanoma, and multiple myeloma as part of a combination regimen.
DATA ON BLADDER CANCER
According to the Urology Care Foundation, bladder cancer is the fifth most common cancer in the United States, and in 2017, expected new cases were more than 80,000.
Additionally, high-risk patients make up 15-44% of those with non-muscle invasive bladder cancer, according to J&J.
In Italy, the Umberto Veronesi Foundation reports that diagnoses of bladder cancer are growing: in 2022 there were 29,200, with an increase of 8% in cases per year compared to 2017. The most affected remain men, who are over 23,000, although in five years female cases have increased by 11%.
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/come-agisce-il-farmaco-di-johnson-johnson-per-il-tumore-alla-vescica/ on Tue, 05 Dec 2023 15:11:14 +0000.