Mitomycin C gel




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.


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