SOMATULINE (lanreotide), somatostatin analogue
ONCOLOGY - New indication
Opinions on drugs - Posted on Jun 10 2016
Reason for request
Extension of inclusion
Substantial clinical benefit in the treatment of non-resectable and non-progressive gastroenteropancreatic neuroendocrine tumours, constituting a possible alternative to simple monitoring.
Insufficient clinical benefit for non-resectable and progressive gastroenteropancreatic neuroendocrine tumours.
- SOMATULINE LP 120 mg now has marketing authorisation in adults in the treatment of non-resectable, locally-advanced or metastatic gastroenteropancreatic neuroendocrine tumours (GEP-NETs) of grades 1 and 2 with a Ki 67 index ≤ 10%, originating from the midgut or pancreas or of unknown origin, after ruling out a primary site at the hindgut.
- Its efficacy relative to placebo has been demonstrated in terms of progression-free survival in patients who received simple therapeutic monitoring (at baseline, stable disease for 3 to 6 months according to RECIST). No benefit on overall survival was demonstrated.
- No data in patients with progressive disease are available.
Clinical Added Value
|no clinical added value||
Évaluation des médicaments