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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. 

Actual benefit

Important

-

Insuffisant


Improvement in actual benefit

V (absence)

-


Therapeutic use

-

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