Ayisha Sharma
News Reporter
Johnson & Johnson has secured FDA approval for a drug-device approach for bladder cancer that could spare patients from having to get their bladders surgically removed.
The company’s TAR-200 was greenlit for non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors, according to a Tuesday release. The patients have been unsuccessfully treated with standard-of-care Bacillus Calmette-Guérin (BCG) therapy.
The product will be marketed as Inlexzo. J&J has not yet responded to an Endpoints News query about pricing.
The drugmaker obtained TAR-200 back in 2019, when it acquired the original developer of the product, Taris Biomedical, in a deal with undisclosed financial terms.
TAR-200 delivers the decades-old chemotherapy drug gemcitabine directly to the bladder over a seven-day period. The drug-releasing system, which has been dubbed a “pretzel,” can be inserted into a patient in just a few minutes without the need for general anesthesia or monitoring. The procedure is carried out in an office setting.
Jennifer Taubert
Wall Street consensus estimates indicate the product could reach $790 million in sales in 2028. In July, J&J’s head of innovative medicine Jennifer Taubert said the company’s internal forecasts for that year are at least three times as high, working out to around $2.4 billion.
“We’ve really designed this product by urologists, for urologists, to seamlessly fit into routine clinical practice, and we really think we’ve got a winner there,” Taubert said on the company’s second-quarter earnings call.
TAR-200 was approved based on results from an open-label Phase 2b study called SunRISe-1. In the trial, 82% of treated patients achieved a complete response (CR), and 51% maintained this response for at least a year.
More than 80,000 people are diagnosed with bladder cancer each year in the US, with most cases being non-muscle invasive at diagnosis, according to the American Cancer Society. Patients with carcinoma in situ make up around 10% of those with non-muscle-invasive disease, J&J said.
The other treatment option for this particular bladder cancer setting is surgery to remove the entire organ, otherwise known as radical cystectomy. The procedure has a lifelong impact on the way patients live, as they will need a stoma or internal pouch to collect and expel urine.
J&J is also testing the product in other forms of non-muscle invasive bladder cancer, including papillary disease-only patients.
AUTHOR
Ayisha Sharma
News Reporter
asharma@endpointsnews.com
