Lanreotide official document review · version 1
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Inside the official reviews
Reviewed 2026-09-19 · Preserved version 1
The tumor study measured progression-free survival
FDA’s December 2014 review describes a 204-participant, randomized, double-blind placebo-controlled trial in unresectable or metastatic, well- or moderately differentiated gastroenteropancreatic neuroendocrine tumors. The primary endpoint combined radiological progression or death. FDA PDF pp. 32, 36 ↗
More findings, study links and document coverage
Delayed progression did not establish longer survival
FDA found longer progression-free survival with lanreotide. Overall-survival data were immature with no apparent difference between groups at that assessment, so these outcomes should not be treated as interchangeable. FDA PDF pp. 32 ↗
Most participants had stable disease before entry
Nearly all participants had stable disease before randomization. That population limits extrapolation of the result to every rapidly progressing tumor or tumor subtype. FDA PDF pp. 32 ↗
The safety account is indication-specific
The reviewed tumor study reported glucose abnormalities, bradycardia and gallbladder findings. Its exposure and population differ from the earlier acromegaly program; this supplement is not a complete review of every lanreotide use. FDA PDF pp. 40 ↗
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.
Somatuline Depot: FDA selected application review ↗
Selected sections reviewed · fda-lanreotide-review-2014 · Document/feed date: 2014-12-16
Application identity and document date were checked in the PDF, independently of the URL year or candidate feed association.
Verified: Somatuline Depot · NDA 022074 · Document dated 2014-12-16. Identity checked on PDF pp. 31.
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: 31, 32, 36, 40 of 199. SHA-256:
1130ab9cde9c9010cc5f49111f51bac7d096d273aef7696d05817de03fbd0a93.
Remaining work
- Review the original acromegaly and later carcinoid-syndrome assessments separately.
- Appraise CLARINET extension and survival follow-up, preserving crossover and enrollment limitations.