Mitomycin gel approved as treatment of adult patients with low grade upper tract urothelial cancer.
Phase III OLYMPUS trial supported the approval for this mitomycin formulation.
Consists of a sustained release formulation of 4 mg of mitomycin per milliliter of a sterile reverse thermal gel, a type of hydrogel the transforms from a viscous liquid windshield to a solid gel at room temperature.
This formulation allows the drug to be instilled into the upper urinary tract in a liquid form, and as it forms a gel depot conforms to renal collecting system, where remains approximately 4-6 hours before dissolved by normal urine flow.
In the study 58% were reported as having a complete response (CR) at 3 months and 29 patients still showed responses at follow-up.
19 patients were still having a CR at 12 months.
The gel formulation, administered through retrograde catheter, that contains mitomycin.
The final analysis showed that 89% of patients maintained their response at 6 months and 84% at 12 months.
The drug was approved by the phase 3 0LYMPUS trial which enrolled 74 patients with primary or recurrent upper tract you real urothelial carcinoma‘s.
Treatment-emergent adverse events: ureteric stenosis (43.7%), urinary tract infection (32.4%), hematuria (31.0%), flank pain (29.6%), dysuria (21.1%), renal impairment (19.7%), and vomiting (19.7%).
The most common grade 3 treatment-emergent adverse event was ureteric stenosis in 8.5% of patients.
Women who are pregnant should not take this drug, as it could cause harm to a fetus or newborn baby,
Should be avoided in patients within a glomerular filtration rate less than 30 ml/min.