J&J's Drug/Equipment Nodding FDA nods offer another option for bladder cancer patients
Patients with bladder cancer have an early but aggressive form of disease, which is unresponsive to the standard of care, now has a new treatment option, an implanted Johnson & Johnson & Johnson drug/device combination product that expands locally to deliver their drug payload to the organs.
J&J products (known in development as TAR-200) will be commercialized under the brand name Inlexzo.
Inlexzo is developed with carcinoma in situ (CIS) for non-muscular invasive bladder cancer (NMIBC), a cancer that is localized to the endocardium of the bladder. This cancer may or may not have papillary tumors, finger-like growth that forms in tissue lining the inner part of the bladder. Standard treatment This type of bladder cancer is Calmette-guérin (BCG), where bacteria promote an immune response to cancer. When bladder cancer does not respond to this immunotherapy, the next treatment option is surgical removal of the bladder. Inlexzo approved the announcement of treatment for adults who have no response to bladder cancer to BCG after the market closed on Tuesday.
Inlexzo manages gemcitabine, a chemotherapy. The product package includes a urine catheter and an elongated detector for inserting the delivery system into the bladder. J&J's regulatory submission was based on a single-arm 2B study that recruited 83 patients. Study participants received a delivery system every three weeks for six months, and then every 12 weeks for 18 months. After each treatment period, the Inlexzo is removed from the bladder.
The trial results showed that the complete response rate to this treatment was 82%. 51% of patients had a duration of 12 months or more. The most common adverse events include frequent urination, urinary tract infections, and pain or discomfort during urination. Inlexzo is not recommended for patients with bladder perforation.
Inlexzo traces its origins to Taris Biomedical, which J&J got an undisclosed sum in 2019. Since then, bladder cancer patients have received another immunotherapy that has not responded to BCG. Last year, the FDA approved Immunitybio's Anktiva, a fusion protein designed to enhance the activity of cancerous immune cells. Another treatment developed by CG oncology was published last year. The biotechnology is currently undergoing a 3-phase test using an oncolytic virus called Cretostimogene. Last week, CG said it expected to submit a biologic application to the FDA in the fourth quarter of this year.
Leerink Partners talked with clinicians about emerging therapies for bladder cancer in the summer. Analyst David Risinger said in a July study noted that the clinicians expressed support for J&J and CG therapy, but said J&J treatment may have logistical advantages. The dose of CG treatment requires pre-washing, biosafety level 2 hood, which is a partially enclosed space that protects clinicians, surrounding environment and interior materials.
By contrast, J&J therapy can be performed in a process that is not as complicated as logically. Cross-trial comparisons put CG treatment on a slightly safe margin, but clinicians told Leerink that they believe these differences are enough to drive physician preference.
“In contrast, factors like cost, profitability and logistical convenience may be the main drivers of absorption,” Risinger said in the notes. “Given its convenience, TAR-200 may have an advantage in a community setting. In addition, TAR-200 is the only treatment evaluated in a head-to-head trial of BCG.”
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