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AAA’s orphan drug Lutathera wins EU green light

The first-in-class drug treats adults with GEP-NET

AAAAdvanced Accelerator Applications’ (AAA) Lutathera (lutetium oxodotreotide) has received European approval to treat adults with unresectable or metastatic, somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours.

Known as GEP-NETs, gastroenteropancreatic neuroendocrine tumours originate from neuroendocrine cells of numerous organs and are often slow growing with “very few effective treatment options”.

The approval is a significant win for French group, who will see the drug become the first theragnostic radiopharmaceutical company on the oncology market.

Stefano Buono, chief executive officer at AAA, said: “This is a historic moment for the company as we are proud to bring this first-in-class drug, and the very first registered Peptide Receptor Radionuclide Therapy (PRRT), to the European NET patient community.

“Numerous clinical studies in the nuclear medicine field have demonstrated the advantages of selectively delivering radiation to tumour cells over certain therapies, and we are committed to advancing this approach to cancer treatment.”

The approval is based on results of the randomised phase III study NETTER-1, which showed a reduction of risk of progression or death of 79% using Lutathera compared to octerotide LAR.

Buono added: “We will continue to work closely with the respective health authorities in each country to make Lutathera widely available.”

The drug has previously received orphan drug designation from both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). AAA are currently awaiting a decision on market access for the treatment in England and Wales from NICE.

Article by
Gemma Jones

9th October 2017

From: Regulatory

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