DOR
“The DOR estimate was 81.2% (95% CI: 74.4, 86.4) at 18 months after 3-month CR as presented in Applicant Figure 3.”
Multi-disciplinary Review · PDF p. 77 · fda.gov ↗
95%estimate was 81.2
FDA record · Cancer
Zusduri (mitomycin)
What FDA's own documents say about Zusduri: what it is approved for, the trials FDA reviewed, the results it reported and the risks on the label.
- Sponsor
- Urogen Pharma
- Application
- NDA 215793
- First approved
- June 12, 2025
- Status
- Approved
- Read from
- 10 FDA documents, 412 pages
What it is approved for
“ZUSDURI is an alkylating drug indicated for the treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).”
Prescribing Information (Label) · PDF p. 2 · fda.gov ↗
Results FDA reported
Sentences from FDA's reviews that give an endpoint's p-value, effect or confidence interval, those reporting a treatment effect first.
Safety
Adverse events the documents discuss most
- death 31 mentions
- hypersensitivity 5 mentions
- headache 2 mentions
- anti-drug antibodies 2 mentions
- left ventricular dysfunction 1 mentions
- anemia 1 mentions
- neutropenia 1 mentions
- thrombocytopenia 1 mentions
Dosing on the label
“The recommended dose of ZUSDURI is 75 mg (56 mL) instilled once weekly for six weeks.”
Prescribing Information (Label) · PDF p. 2 · fda.gov ↗
“The recommended dose of ZUSDURI is 75 mg (56 mL) instilled once weekly for six weeks into the bladder via a urinary catheter.”
Prescribing Information (Label) · PDF p. 3 · fda.gov ↗
FDA documents read
| Document | Date | Pages | Copy | sha256 |
|---|---|---|---|---|
| Prescribing information, original approval215793s000lbl.pdf | June 13, 2025 | 26 | 1460e5f984bc | |
| Approval letter215793Orig1s000ltr.pdf | June 13, 2025 | 5 | 42d29d016dc5 | |
| Administrative Correspondence215793Orig1s000AdminCorres.pdf | July 24, 2026 | 68 | 6ae8c66c09e0 | |
| Approval Letter215793Orig1s000Approv.pdf | July 24, 2026 | 8 | eab9f7bc8d9d | |
| Chemistry Review215793Orig1s000ChemR.pdf | July 24, 2026 | 37 | cceda1277494 | |
| Prescribing Information (Label)215793Orig1s000Lbl.pdf | July 24, 2026 | 32 | 31a4689a4156 | |
| Multi-disciplinary Review215793Orig1s000MultidisciplineR.pdf | July 24, 2026 | 174 | eb59d944a2c9 | |
| Proprietary Name Review215793Orig1s000NameR.pdf | July 24, 2026 | 19 | ecc40f9aabe2 | |
| Officer/Employee List215793Orig1s000OEList.pdf | July 24, 2026 | 2 | cee086b77770 | |
| Other Reviews215793Orig1s000OtherR.pdf | July 24, 2026 | 41 | 405514ec5962 |
Checked against FDA's copies on September 30, 2026. The sha256 is the fingerprint of the file that was read: download it from fda.gov and compare. Quotes come from the text of each file as read; pages FDA stored as images were read by OCR and are marked.
Generated automatically (auto): the trials, names and dates are drafted from the documents by rules, with no language model; see the method.
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