Johnson & Johnson (J&J) has announced that its investigational intravesical gemcitabine releasing system has been accepted for priority review by the US Food and Drug Administration (FDA) to treat high-risk non-muscle invasive bladder cancer (NMIBC).
The decision on TAR-200 specifically applies to patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk NMIBC with carcinoma in situ, with or without papillary tumours.
J&J’s new drug application was supported by results from the phase 2b SunRISe-1 trial, in which TAR-200 monotherapy was associated with a complete response (CR) rate of 82.4%, with 52.9% of patients remaining cancer-free for at least one year after achieving a CR.
The American Cancer Society estimates that around 84,870 people will be diagnosed with bladder cancer in the US this year, with NMIBC accounting for the majority of new cases.
Radical cystectomy, the removal of the bladder and nearby structures and organs, is currently recommended for NMIBC patients who fail standard-of-care BCG therapy. However, as NMIBC usually affects older patients, many may be unwilling or unfit to undergo this procedure.
TAR-200 is designed to provide sustained local delivery of the chemotherapy drug gemcitabine into the bladder. The system is placed into the bladder by a healthcare professional using a co-packaged urinary placement catheter in an outpatient setting in under five minutes.
Yusri Elsayed, global therapeutic area head, oncology, J&J Innovative Medicine, said TAR-200 “represents an innovation in drug delivery that has not been seen in decades”, adding that the FDA priority review “underscores [the company’s] mission to fundamentally change the way urologists treat certain types of bladder cancer”.
Bladder cancer is a key focus area for J&J, and the company recently received recommendations from the National Institute for Health and Care Excellence and Scottish Medicines Consortium for use of its pan-FGFR3 tyrosine kinase inhibitor Balversa (erdafitinib) in a subset of urothelial cancer (UC) patients.
The drug can now be used on the NHS in England, Wales and Scotland to treat unresectable or metastatic UC in adults who are harbouring susceptible FGFR3 genetic alterations and have received at least one line of therapy containing a PD-1 or PD-L1 inhibitor.