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Advanced Accelerator Applications Lutathera (lutetium (177Lu) oxodotreotide) for Treatment of Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) Recommended for NHS Funding in England

Advanced Accelerator Applications
Posted on: 20 Jul 18

Advanced Accelerator Applications statement

Advanced Accelerator Applications, a Novartis company, welcomes the publication of the National Institute for Health and Care Excellence (NICE) Final Appraisal Document (FAD) for Lutathera® (lutetium (177Lu) oxodotreotide), for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults.

NICE has announced today, 20th July, that it has recommended lutetium (177Lu) oxodotreotide as a treatment option in adults within its marketing authorisation and for all approved indications of progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs). This means that the treatment will now be available to patients via the NHS in England. The European Commission (EC) approved marketing authorisation of lutetium (177Lu) oxodotreotide in September 2017.

Lutetium (177Lu) oxodotreotide is a 177Lu-labeled somatostatin analog peptide. It belongs to an innovative form of treatments called Peptide Receptor Radionuclide Therapy (PRRT), which involves targeting tumours with radiolabeled molecules that bind to specific receptors expressed by the tumour.

We are very pleased to receive a positive recommendation from NICE,” commented Germo Gericke, M.D., Head of Research and Development at Advanced Accelerator Applications. “Lutetium (177Lu) oxodotreotide is the first treatment of its kind to receive regulatory approval and it is our hope that being recognised by NICE as a cost-effective treatment for all approved indications will facilitate broad availability of this therapy for GEP-NET patients in England.

This positive recommendation is based on key evidence, including the results of a randomised, open label, phase 3 study, NETTER-1, in 229 patients with inoperable, metastatic or locally advanced, progressive midgut NET, which included head to head data comparing lutetium (177Lu) oxodotreotide with a double dose of Octreotide LAR in patients with inoperable midgut NETs progressive under standard Octreotide LAR treatment and overexpressing somatostatin receptors.

The primary outcome was progression-free survival (PFS) which was defined as time from randomisation to disease progression. The median PFS was 28.4 months for lutetium (177Lu) oxodotreotide and 8.5 months in Octreotide LAR.[1,2]

Additionally, data to inform efficacy was used from the Erasmus phase 1/2 trial. This was conducted in more than 1,200 patients with a wide range of NET indications including foregut (pancreatic), midgut and hindgut.[2]

The most common side effects seen with Lutathera treatment are nausea and vomiting, which occurred at the start of the infusions in around half of patients and may be related to the amino acid infusion.[2] Other common side effects affecting more than 1 in 10 patients are thrombocytopenia, lymphopenia, anaemia, pancytopenia, tiredness and reduced appetite.[2]

“The clinical trial data and real-life experience of lutetium (177Lu) oxodotreotide indicate that this is a clinically beneficial treatment for GEP-NET patients with advanced disease,” stated Professor Martyn Caplin, Professor of Gastroenterology and Tumour Neuroendocrinology at the Royal Free London Hospital and University College London. “This recommendation from NICE is perhaps the most important approval of any treatment in NETs in a long time. Lutetium (177Lu) oxodotreotide fulfils an unmet need in this population of patients, who have progressed on other therapies.”

GEP-NETs, are a group of tumours originating in the neuroendocrine cells of numerous organs. The estimated incidence of gastrointestinal NETs in the UK is approximately 2.65 per 100,000 per year, while the estimated incidence of pancreatic NETs in the UK is less than 0.2 per 100,000 per year.[3] However, since NETs are often slow-growing and associated with prolonged survival, the prevalence of NETs is relatively high.[4]

 

Disclaimer

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

 

About Advanced Accelerator Applications S.A.

Advanced Accelerator Applications, a Novartis company, is an innovative radiopharmaceutical company developing, producing and commercializing radioligand theragnostics. 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/.

 

References:

1. Advance Accelerator Applications. Lutathera Summary of Product Characteristics 2017.

2. European Medicines Agency. European Public Assessment Report (EPAR) for Lutathera. 2017.

3. Ramage J, Ahmed A, Ardill J, Bax N, Breen JD, Caplin ME, Corrie P, Davar J, Davies A H, Lewington V, et al. Guidelines for the management of gastroenteropancreatic neuroendocrine (including carcinoid) tumours (NETs). Gut 2012;61: 6─32.

4. Yao JC, Hassan M, Phan A, et al. One hundred years after “carcinoid”: epidemiology of and prognostic factors for neuroendocrine tumors in 35,825 cases in the United States. J Clin Oncol 2008;26:306372.

 

Editor's Details

Advanced Accelerator Applications

Last updated on: 20/07/2018

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