LUTATHERA (177 Lutécium oxodotréotide) - TNE pancréatiques

 Key points

Approval of reimbursement only for the treatment of unresectable or metastatic, progressive, well-differentiated (G1 and G2) somatostatin receptor positive‑pancreatic neuroendocrine tumours (NETs) in adults.

Therapeutic improvement?

No improvement in relation to the therapeutic strategy.

Role in therapeutic strategy?

The Committee points out that the initiation of LUTATHERA (177Lutetium oxodotreotide) treatment must be discussed within the framework of multidisciplinary team meetings as part of the NET-specific national network, RENATEN, designated by INCa.

The treatment of pancreatic NETs consists of managing tumour syndrome and any potentially associated secretory syndrome, which has a significant impact on patient quality of life and morbidity.

Considering:

• non-comparative data from the phase II OCLURANDOM study and the phase IV NETTER-R study suggesting the efficacy of LUTATHERA;
• a benefit in progression-free survival which has yet to be confirmed by a randomised study;
• the known usage of this product in intestinal NETs;
• the known acceptable safety profile of this proprietary product,

the Commission considers that LUTATHERA (177Lutetium oxodotreotide) is a second-line treatment for unresectable or metastatic, progressive, well-differentiated (G1 and G2), somatostatin receptors positive-pancreatic NETs expressing somatostatin receptors.

Due to the lack of comparative data, the role of radioligand therapy (RLT) compared to sunitinib or everolimus is not known.

Haematotoxic risk should be monitored, especially in patients with previous exposure to alkylating chemotherapy protocols.

Special recommendations

The Committee recommends that the initiation of LUTATHERA (177Lutetium oxodotreotide) treatment should be discussed within the framework of multidisciplinary team meetings as part of the NET-specific national network, RENATEN, designated by INCa.