Are you a healthcare provider?
This site is intended for U.S. healthcare providers only.
By clicking YES, you attest you are a healthcare provider licensed in the U.S.
In adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic GEP-NETs.1,3
The Median PFS for Somatuline Depot was not yet reached at 22 months (95% CI NE, NE) compared with 16.6 months for placebo (95% CI: 11.2-22.1).1
Number of events (N=204): Somatuline Depot 32 (31.7%) vs placebo 60 (58.3%).1
CI=Confidence interval. NE=Not reached at 22 months.1
Most common adverse reactions (greater than 10%) are abdominal pain, musculoskeletal pain, vomiting, headache, injection site reaction, hyperglycemia, hypertension, and cholelithiasis.1
Please see CLARINET study design and Patient Information below.
The majority (84%) of patients in CLARINET had not received prior pharmacologic therapy for GEP-NETs. Some patients (16%) received prior therapy.3
Patients were excluded if they received3:
— An SSA at any time, unless they received it >6 months prior to study entry and for <15 days
— Interferon, chemoembolization, or chemotherapy: <6 months prior to study entry
*CLARINET=Controlled Study of Lanreotide Antiproliferative Response In NeuroEndocrine Tumors.3
†Administered every 28 days by deep subcutaneous injection. Follow-up visits occurred at Weeks 12, 24, 36, 48, 72, 96.3
‡Assessed by a central independent radiological review in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.3
CLARINET included patients with unresectable, well- to moderately-differentiated, locally advanced or metastatic GEP-NETs, a range of hepatic tumor loads, and varying primary tumor locations (foregut/pancreas, midgut, or hindgut).
To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127 or FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.