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Lutathera first Lutetium-177 containing radiopharmaceutical with European marketing authorisation

Published on 05.10.2017

In a press release dated 29th September 2017, Advanced Accelerator Applications (AAA) anounces the European Commision approval of 177Lu-Oxodotreotide (aka 177Lu-DOTATATE) for the treatment of unresectable or metastatic neuroendocrine tumors.

The molecule will be marketed under the trade name Lutathera.

Lutathera is the first therapeutical radiopharmaceutical containing lutetium-177 to receive European marketing approval. The exact indication is "...the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.” 

The approval was based on data phase >1200 phase I/II patients treated in Rotterdam and from the Netter-1 trial, published in January in the New England Journal of Medicine and which featured as paper of the month September on the Belnuc website.

The results of this trial were also presented during the General Assembly on March 19th 2016 by Prof. Dr Dik Kwekkeboom from the Erasmus Hospital in Rotterdam, the Netherlands.

We take this opportunity to pay tribute and our deepest respects to this true pioneer of nuclear medicine, who passed away on March 8th 2017, not even two months after the publication of his opus magnum.

His death was mourned in the Journal of nuclear medicine and by the Neuroendocrine tumor societies  ENETS and NANETS.

With not only a staunch effect on progression-free survival (with a hazard ratio of 0.21 in the aforementioned Netter-1 trial), but also very compeling hints of an impact on overall survival (hazard ratio of 0.54 in the most recent analysis mentioned in the Summary of Product Characteristics, with 28 deaths in the Lutathera arm and 43 in the control arm), Lutathera will probaly be the first beta-emitting radiopharmaceutical with a solidly demonstrated positive effect on overall survival.

We welcome this novel therapeutic molecule and are looking forward to its reimbursement by the RIZIV/INAMI.

The original AAA press release can be found below.

2017-09-29-PR-EMA-Approval-Lutathera-ENG.pdf
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