Radiopharmaceutical Lutathera® now reimbursed in Quebec for cancer patients with advanced gastroenteropancreatic neuroendocrine tumours (GEP-NETs)

• Lutathera is the first and only therapeutic radiopharmaceutical indicated in the treatment of GEP-NETs in Canada
• Lutathera directly targets tumours by binding to cancer cell receptors

MISSISSAUGA, ON, Oct. 1, 2020 /CNW/ - Advanced Accelerator Applications Canada Inc. (AAA) is pleased to announce that eligible Quebec patients with gastroenteropancreatic neuroendocrine tumours (GEP-NETs) – a life-threatening form of cancer affecting the neuroendocrine cells of the pancreas and gastrointestinal tract - now have access to the innovative new radiopharmaceutical therapy, Lutathera^® (lutetium (¹⁷⁷Lu) oxodotreotide).

The Quebec Ministry of Health and Social Services has approved treatment with Lutathera for GEP-NETs patients with advanced disease that is metastatic or not removable by surgery and has progressed despite standard somatostatin analogue therapy and whose ECOG (Eastern Clinical Oncology Group) score is 0 to 2¹.

"Patients with advanced GEP-NETs who are not eligible for surgery and whose disease continues to progress have few options. We are very pleased to be the first centre in Quebec to provide this innovative targeted therapy." said Dr. Petr Kavan, a medical oncologist at the Jewish General Hospital. "It provides a much-needed new option to manage this rare cancer which can take several years to be correctly diagnosed, delaying the opportunity for patients to access appropriate treatment."

Lutathera is a radiopharmaceutical that is given to patients as an infusion in an outpatient hospital setting. Lutathera targets tumours with certain proteins, called somatostatin receptors, on their outer surface in order to deliver radioactivity directly to the tumour. The radioactivity causes damage and eventually kills cancer cells while leaving normal cells intact.

"We are very pleased that Lutathera has been recognized as an important therapy by the Quebec government. This is a significant advance in the management of GEP-NETs patients," said Dr. Norman Laurin, President of the Association des Médecins Spécialistes en Médecine Nucléaire du Québec (Quebec Association of Nuclear Medicine Specialists). "As other nuclear medicine centres in Quebec make Lutathera available, patients will have the opportunity to receive treatment closer to home."

Neuroendocrine tumours (NETs) are abnormal growth of cells (neoplasms) that come from cells of the diffuse neuroendocrine system². NETs usually grow slowly and can take anywhere between five and seven years to diagnose, with patients often misdiagnosed during this time as their symptoms can be similar to many other more common conditions². Often by the time a NETs patient receives a diagnosis, the tumour has spread and metastasized to other parts of the body². NETs tumours are considered complex to treat because both tumor growth and hormonal function must be addressed ². 

"The Health Canada approval and now availability of Lutathera in Quebec are important milestones for GEP-NETs patients with limited treatment options. AAA Canada is committed to bringing innovative radiopharmaceutical therapies to cancer patients in Canada," said Lyndal Walker, President & General Manager, Advanced Accelerator Applications Canada Inc.

Lutathera was approved by Health Canada in 2019 for the treatment of unresectable (not removable by surgery) or metastatic, well-differentiated, somatostatin receptor-positive (expressing the somatostatin receptor) gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults with progressive disease³. Quebec joins Nova Scotia to provide access to Lutathera for eligible patients with GEP-NETs.

About Lutathera^®

Lutathera^® (lutetium (¹⁷⁷Lu) oxodotreotide) is a lutetium Lu 177-labeled somatostatin analog peptide. Lutathera belongs to a class of treatments called Peptide Receptor Radionuclide Therapy (PRRT). Lutathera is comprised of a targeting molecule which carries a radioactive component. The approval of Lutathera is based on results of the pivotal Phase 3 NETTER-1 study which was published in January 2017 in The New England Journal of Medicine⁴ and a single-arm, open-label study conducted by Erasmus Medical Center in Rotterdam, Netherlands^3,5. Please see Important Safety Information and Full Prescribing Information here.

About Advanced Accelerator Applications Canada Inc.

Advanced Accelerator Applications Canada Inc., a Novartis company, is an innovative radiopharmaceutical company developing, producing and commercializing radioligand theragnostics (pairings of therapeutic and diagnostic drugs based on the same targeting molecule) for oncology. AAA is an established leader in radiopharmaceuticals for Positron Emission tomography (PET) and Single-Photon Emission Computed Tomography (SPECT) diagnostic imaging, mainly used in clinical oncology, cardiology and neurology. For more information, please visit: https://www.adacap.com/.

Lutathera is a registered trademark.

References

1.	Régie de l'assurance maladie du Québec (RAMQ), Liste des médicaments fournis en établissement, 30 septembre 2020 accessed September 30, 2020 at: https://www.ramq.gouv.qc.ca/fr/media/9031 and Institut national d'excellence en santé et services sociaux (INESSS), Extrait d'avis au ministre; Lutathera (tumeurs neuroendocrines gastro-entéro-pancréatiques), accessed September 30, 2020 at: https://www.inesss.qc.ca/fileadmin/doc/INESSS/Inscription_medicaments/Avis_au_ministre/Fevrier_2019/Lutathera_2019_01.pdf
2.	Carcinoid-Neuroendocrine Tumour Society Canada, NET One Page Facts, accessed September 30, 2020, at: https://ed2.b79.myftpupload.com/wp-content/uploads/2020/05/Neuroendocrine-Tumours-One-Pager.pdf
3.	Advanced Accelerator Applications, Lutathera™ Product Monograph, January 9, 2019.
4.	Strosberg J, El-Haddad G, Wolin E, et al. Phase 3 Trial of 177Lu-Dotatate for Midgut Neuroendocrine Tumors. N Engl J Med 2017; 376:125-35.
5.	Brabander T, van der Zwan WA, Teunissen JJM, et al. Long-Term Efficacy, Survival, and Safety of [177Lu-DOTA0,Tyr3]octreotate in Patients with Gastroenteropancreatic and Bronchial Neuroendocrine Tumors. Clin Cancer Res. 2017;23(16):4617-4624. doi:10.1158/1078-0432.CCR-16-2743

SOURCE Advanced Accelerator Applications Canada Inc.

Media contacts: Advanced Accelerator Applications, Rachel Levine, [phone], [email protected]; Spectrum Advisors, [phone], [email protected]