Johnson & Johnson (J&J) has secured the US Food and Drug Administration’s (FDA) approval for Inlexzo (gemcitabine intravesical system) to treat certain bladder cancers.
Inlexzo is indicated for adults with non-muscle invasive bladder cancer (NMIBC) who are unresponsive to Bacillus Calmette-Guérin (BCG) therapy.
It is the first intravesical drug-releasing system (iDRS) that delivers cancer medication directly to the bladder and remains there for three weeks per cycle.
The system can be administered in an outpatient setting without general anaesthesia, thereby making it a less invasive treatment option for bladder preservation.
Inlexzo is said to provide a new treatment option for BCG-unresponsive bladder cancer patients who are ineligible for bladder removal surgery.
Johnson & Johnson executive vice president, innovative medicine worldwide chairman Jennifer Taubert said: “When we acquired this novel therapy in 2019, our ambition was to give patients with bladder cancer a renewed sense of hope and belief.
“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.”
The FDA approval is based on results from the Phase 2b SunRISe-1 clinical trial, where Inlexzo showed an 82% complete response rate.
The data showed that 51% of patients treated with Inlexzo maintained the response for at least one year, validating its durable results.
Common adverse reactions reported during the study include urinary frequency, infection, dysuria, and bladder irritation, among others.
Furthermore, Johnson & Johnson is extending its support for enhancing access to the treatment through its comprehensive patient support programme, J&J withMe.
Johnson & Johnson innovative medicine research and development (R&D) executive vice president John Reed said: “We are proud of the science that has brought us to this historic moment.
“Inlexzo is a novel therapy with powerful efficacy and a demonstrated safety profile.
“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.”
