The US FDA has approved mitomycin intravesical solution for adult patients with recurrent, low-grade intermediate-risk, non-muscle invasive bladder cancer (NMIBC). The solution contains mitomycin and a sterile hydrogel for sustained release. It is designed for potent tumor ablation. Clinical evidence In a clinical trial involving 240 adult patients with low-grade NMIBC recurring after transurethral resection of bladder tumor, mitomycin intravesical solution achieved a 78% complete response (CR) at three months.
The duration of response ranged from 0 to over 25 months. Notably, 79% of responders maintained CR for at least 12 months. Dosage and administration Administer via intravesical instillation only Recommended dose: 75 mg in 56 mL Instill once weekly for six weeks Contraindications Perforation of the bladder Prior hypersensitivity reaction to mitomycin or any component of the…
