Johnson & Johnson (J&J) has received approval from the US Food and Drug Administration (FDA) for Inlexzo (gemcitabine intravesical system), a new treatment option for patients with specific types of bladder cancer.
The approval is said to address the need for alternatives for individuals who have not responded to Bacillus Calmette-Guerin (BCG) therapy and for those who are either unwilling or ineligible for radical cystectomy, a surgical procedure to remove the bladder.
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Previously known as TAR-200, Inlexzo is specifically indicated for adult patients with BCG-unresponsive, non-muscle invasive bladder cancer (NMIBC) that includes carcinoma in situ (CIS), with or without the presence of papillary tumours.
The Inlexzo system aims to facilitate bladder preservation and is claimed to be the first intravesical drug-releasing system (iDRS) that allows for prolonged local delivery of a cancer treatment directly into the bladder.
The device remains in the bladder for three weeks during each treatment cycle, with a maximum of 14 cycles.
Healthcare professionals can insert Inlexzo into the bladder using a co-packaged urinary catheter and stylet, a process that takes only a few minutes and does not require general anaesthesia or extensive post-insertion monitoring.
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By GlobalDataThe FDA’s decision is based on findings from the SunRISe-1 Phase IIb clinical trial, which was a single-arm, open-label study.
The results indicated that 82% of patients with BCG-unresponsive NMIBC treated with Inlexzo achieved a complete response (CR), indicating no detectable signs of cancer following treatment, according to the company.
Furthermore, 51% of these patients maintained a complete response for at least one year.
The primary endpoint of the study was the complete response rate, while secondary endpoints included the duration of response.
Johnson & Johnson Innovative Medicine R&D executive vice-president John Reed said: “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 J&J to accelerate innovation and deliver this important therapy to patients.”
