Named Patient Program for Mitomycin for Pyelocalyceal Solution

UroGen Pharma

Status

Conditions: Urothelial Carcinoma Recurrent; Urothelial Carcinoma; Urothelial Carcinoma Ureter; Urothelial Carcinoma of the Renal Pelvis and Ureter; Urothelial Carcinoma Ureter Recurrent; Urothelial Cancer of Renal Pelvis

Treatments: Drug: Mitomycin for pyelocalyceal solution

Study type: Expanded Access

Funder types: Other; Industry

Identifiers

NCT05494411

UT003

Details and patient eligibility

About

This program provides controlled, pre-approval access to JELMYTO in response to unsolicited requests by physicians, hospitals, pharmacies, distributors, ministries of health or other parties on behalf of specific, or named patients, in select countries where JELMYTO has not yet received a marketing authorization and in situations when patients have exhausted all available treatment options.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients who are suitable to receive JELMYTO and for whom there is reasonable expectation that JELMYTO may provide clinical benefit based on the medical judgment of their prescribing physician.