The FDA has signed off on Johnson & Johnson’s highly anticipated bladder cancer drug Inlexzo, marking an advance in the ability to care for patients who otherwise face bladder removal and limited treatment options.
Inlexzo, previously called TAR-200, can now treat patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
The drug-releasing system combo allows for extended release of the chemotherapy gemcitabine directly to patients' bladders through an intravesical system that can be placed in minutes in an outpatient setting, with no general anesthesia needed, J&J said in a Sept. 9 release.
Before the approval, the typical treatment route for NMIBC patients who don’t respond to standard-of-care BCG therapy was a radical cystectomy to remove the entire bladder. It's a life-altering and risky procedure that's not appropriate for many patients.
J&J’s offering, meanwhile, provides a “potentially practice-changing” treatment, the company said.
“We are proud of the science that has brought us to this historic moment,” John Reed, M.D., Ph.D., head of R&D at J&J Innovative Medicine, said in a statement. “As the only major healthcare company that hosts both pharmaceuticals and medical devices, we leveraged the speed and scale of Johnson & Johnson to accelerate innovation and deliver this important therapy to patients.”
J&J picked up the asset from Taris Biomedical in 2019 with hopes to “give patients with bladder cancer a renewed sense of hope and belief,” Jennifer Taubert, J&J's head of Innovative Medicine, commented. “In an area that has seen little progress for more than 40 years, Inlexzo delivers a first-of-its-kind breakthrough innovation with a bright future ahead.”
In a phase 2b study, 82% of Inlexzo-treated patients experienced a complete response without the need for reinduction, with 51% maintaining the response for at least one year. The complete response rate is the highest recorded among currently available therapies, Mark Wildgust, Ph.D., vice president of oncology global medical affairs for J&J Innovative Medicine, said in an interview with Fierce Pharma earlier this year.
With its high complete response rate and its convenience factor, J&J believes Inlexzo will set itself apart from other bladder cancer offerings such as Merck’s Keytruda, Ferring Pharmaceuticals’ gene therapy Adstiladrin and ImmunityBio’s immunotherapy Anktiva, which is used alongside the BCG vaccine. The company has high hopes for the drug’s market potential.
“In all the research that we have done, I have absolutely no reason to believe that they will use anything else but us once they fail BCG,” the president of J&J’s solid tumor business, Biljana Naumovic, told Fierce Pharma in April. She acknowledged, however, that the drug won’t reach that level of market dominance right away.
J&J has already set up a patient support program and a Care Navigator offering educational resources at no cost to patients. Inlexzo is being further studied across patients with MIBC and those with NMIBC in four ongoing clinical trials.