Leuprolide official document review · version 1
This page preserves this version's findings, scope and source pins. Open the current profile →
Inside the official reviews
Reviewed 2026-09-19 · Preserved version 1
This application relied on a formulation-specific bridge
FDA’s Camcevi review describes a 505(b)(2) application relying in part on prior findings for Lupron, with supporting clinical bridging data. It is not a new trial of every leuprolide formulation or indication. FDA PDF pp. 13 ↗
More findings, study links and document coverage
The pivotal study was uncontrolled
The reviewed trial enrolled 137 patients with advanced prostate cancer in a single-arm, open-label design. Without a randomized comparator, it cannot establish superiority over other androgen-deprivation treatments. FDA PDF pp. 13 ↗
Testosterone suppression was the primary endpoint
FDA evaluated whether testosterone suppression was achieved and maintained from day 28 through day 336. That endpoint is distinct from demonstrating longer survival or better patient-reported quality of life in this trial. FDA PDF pp. 13, 18 ↗
The extension was a smaller safety follow-up
An additional 30 patients continued into the safety extension after day 336. They should not be counted as an independent confirmatory trial or as long-term observations for all original participants. FDA PDF pp. 13 ↗
Read the separate U.S. label account → Label version and indication scope are preserved there; these agency reviews describe their own dated evidence.
Document coverage
Selected sections read in 1 of 1 inventoried documents; 0 not yet reviewed. Reading selected sections does not establish complete appraisal of a document.
One selected official document from the retained EMA document inventory or an independently retrieved FDA application package. Other formulations, later variations, national records and the wider source inventory remain outside this reading. EMA inventory source ↗
Inspect documents, application identities and source pins
Page references use one-based PDF file pages, which can differ from printed page numbers. Candidate feed associations are not verified application identities.
Camcevi: FDA selected application review ↗
Selected sections reviewed · fda-leuprolide-review-2021 · Document/feed date: 2021-05-12
Application identity and document date were checked in the PDF, independently of the URL year or candidate feed association.
Verified: Camcevi · NDA 211488 · Document dated 2021-05-12. Identity checked on PDF pp. 2.
Selected identity, clinical-summary and benefit-risk sections only; this is not a full-document or all-indication appraisal.
Retrieved 2026-09-19. Read PDF pages: 2, 13, 18 of 167. SHA-256:
d115a3d1c53c53ff80dfe0b6f5cd9f6caa5d963733f45199d78bb049105f5db4.
Remaining work
- Review other leuprolide formulations and indications separately from Camcevi.
- Reconcile the pivotal protocol, publication and longer follow-up before making patient-centered outcome claims.