Originally published by our sister publication Clinical Oncology News
By Clinical Oncology News Staff
The FDA approved the gemcitabine intravesical system (Inlexzo, Janssen Biotech) for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non–muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. The gemcitabine intravesical system is co-packaged with a urinary catheter and stylet used for insertion through the urinary catheter into the bladder.
Efficacy was evaluated in cohort 2 of SunRISe-1 (ClinicalTrials.gov Identifier: NCT04640623), a single-arm, multicenter trial enrolling 83 patients with BCG-unresponsive NMIBC with CIS with or without papillary tumors after transurethral resection of bladder tumor (TURBT). Patients received the gemcitabine intravesical system into the bladder every three weeks for six months, followed by once every 12 weeks for up to 18 months.
Tumor status was assessed with cystoscopy and urine cytology every 12 weeks during the initial two years of treatment, after which cystoscopy was performed at least every 24 weeks. Mandatory biopsies were performed at 24 and 48 weeks after treatment initiation.
The major efficacy outcome measures were complete response (CR) at any time (defined as negative results for cystoscopy [with TURBT/biopsies as applicable] and urine cytology) and duration of response (DOR). The CR assessment at each timepoint was based on central pathology review.
The CR rate was 82% (95% CI, 72%-90%), and 51% of patients with a CR had a DOR of at least 12 months.
The prescribing information includes warnings and precautions describing the risks of administering the gemcitabine intravesical system in patients with a perforated bladder, the risk for metastatic bladder cancer with delayed cystectomy, MRI safety, and embryo-fetal toxicity.
The gemcitabine intravesical system delivers 225 mg of gemcitabine into the bladder, with an indwelling period following each insertion of three weeks prior to removal. The gemcitabine intravesical system is inserted once every three weeks for up to six months (eight doses), followed by once every 12 weeks for up to 18 months (six doses), or until persistent or recurrent high-grade NMIBC, disease progression or unacceptable toxicity.
Full prescribing information for the gemcitabine intravesical system will be posted on Drugs@FDA.
Based on a press release from the FDA.
