Johnson & Johnson announced that the FDA has approved Inlexzo, its gemcitabine intravesical drug delivery system, for patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.
Formerly known as TAR-200, Inlexzo is placed in the bladder by a healthcare professional using a co-packaged urinary placement catheter in an outpatient procedure that takes less than five minutes, without the need for general anesthesia or extended monitoring. Once placed, Inlexzo remains in the bladder for three weeks per treatment cycle, for up to 14 cycles.
According to J&J, Inlexzo is the first and only intravesical drug-releasing system (iDRS) to provide extended local delivery of chemotherapy directly into the bladder. The FDA granted the therapy priority review earlier this year.
The approval was supported by results from the Phase 2b SunRISe-1 trial, which showed an 82.4% complete response rate, with 52.9% of patients remaining cancer-free for at least one year or more. Most adverse reactions were reported as mild to moderate.
We are proud of the science that has brought us to this historic moment,” said Dr. John Reed, EVP, R&D, Innovative Medicine, J&J. “Inlexzo is a novel therapy with powerful efficacy and 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.