Radiopharmaceutical cancer treatment Lutathera® now available to Ontario patients with midgut neuroendocrine tumours (NETs)

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

MISSISSAUGA, ON, Oct. 8, 2020 /CNW/ - Eligible cancer patients in Ontario midgut neuroendocrine tumours (NETs) now have access to a new innovative radiopharmaceutical therapy, Lutathera^® (lutetium (¹⁷⁷Lu) oxodotreotide) from Advanced Accelerator Applications Canada Inc. (AAA). This news addresses the need for additional treatment options for this life-threatening cancer affecting the neuroendocrine cells of the pancreas and gastrointestinal tract.

The Ontario funding criteria covers the treatment of adult patients with somatostatin receptor-positive (SSR+) midgut NETs whose disease has progressed on a somatostatin analogue and is unresectable (not treatable by surgery). Eligible patients include those with progressed SSR+ midgut (defined as jejunoileum and proximal in the NETTER-1 trial) NETs and good performance status.

"Having access to Lutathera in Ontario is good news for treating physicians as well as for patients who previously had very limited options available to them," said Dr. Christopher O'Brien, President of the Ontario Association of Nuclear Medicine.

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 thrilled with the Ontario government's decision. Having access to a much-needed treatment as a standard of care brings new hope to patients and families impacted by this disease," said Jackie Herman, President of the Canadian Neuroendocrine Tumour Society (CNETS), an organization which provides support to patients and others affected by the disease. "We would like to see the availability of Lutathera extend to GEP-NETs patients in all provinces across Canada."

Neuroendocrine tumours (NETs) are abnormal growth of cells (neoplasms) that come from cells of the diffuse neuroendocrine system¹. 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 conditions¹. Often by the time a NETs patient receives a diagnosis, the tumour has spread and metastasized to other parts of the body¹. NETs tumours are considered complex to treat because both tumour growth and hormonal function must be addressed¹. 

"This is an important step forward for GEP-NETs patients in Ontario. AAA Canada is committed to ensuring the availability and supply of Lutathera, the first therapeutic radiopharmaceutical therapy indicated for the treatment of GEP-NETs 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 disease²

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 Medicine³ and a single-arm, open-label study conducted by Erasmus Medical Center in Rotterdam, Netherlands^2,4. 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.	Canadian Neuroendocrine Tumour Society (CNETS), NET One Page Facts, accessed October 5, 2020, at: https://ed2.b79.myftpupload.com/wp-content/uploads/2020/05/Neuroendocrine-Tumours-One-Pager.pdf
2.	Advanced Accelerator Applications, Lutathera™ Product Monograph, January 9, 2019.
3.	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.
4.	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]