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LUTATHERA (177Lutetium oxodotreotide), radiopharmaceutical

ONCOLOGY - New medicinal product
Opinions on drugs - Posted on Nov 28 2018

Reason for request

Inclusion

Important clinical benefit in well-differentiated (G1 and G2), progressive, unresectable or metastatic intestinal neuroendocrine tumours, expressing somatostatin receptors in adults, and moderate clinical improvement compared to octreotide CR 60 mg administered alone.  

Insufficient level of evidence to justify its reimbursement in well-differentiated (G1 and G2), progressive, unresectable or metastatic non-intestinal neuroendocrine tumours, expressing somatostatin receptors.

 

  • LUTATHERA 370 MBq/mL has a Marketing Authorization (MA) in the treatment of well-differentiated (G1 and G2), progressive, unresectable or metastatic gastroenteropancreatic neuroendocrine tumours (GEP-NET), expressing somatostatin receptors in adults.

  • In intestinal NETs, the superiority of the progression-free survival of LUTATHERA, in combination with octreotide CR 30 mg has been demonstrated compared to octreotide CR 60 mg alone. The progression-free survival median was not reached in the LUTATHERA and octreotide CR 30 mg combination group and was 8.5 months in the comparator group. A conservative intermediate analysis from an ongoing study did not demonstrate a difference in overall survival between the 2 treatment groups.

  • In non-intestinal NETs, more data is needed to support the reimbursement of LUTATHERA.

 

 


Actual benefit

Important

-

Insuffisant


Improvement in actual benefit

III (modéré)

-