Health Canada approves oral treatment (Pr)AFINITOR® (everolimus) for progressive, non-functional GI and lung neuroendocrine tumours (NET)

• Addresses unmet need for rare cancers with poor prognoses and limited treatment options^1,2

DORVAL, QC, July 11, 2016 /CNW/ - Novartis today announced that Health Canada has approved AFINITOR^® (everolimus) tablets for the treatment of unresectable, locally advanced or metastatic, well-differentiated, non-functional neuroendocrine tumours (NET) of gastrointestinal (GI) or lung origin in adults with progressive disease.³

NET are a rare type of cancer that originate in neuroendocrine cells throughout the body, and are most often found in the GI tract, lungs or pancreas.⁴ NET are defined as functional or non-functional, the latter accounting for more than 70% of cases.⁵  Non-functional GI NET may present with symptoms caused by tumour growth, such as intestinal obstruction, abdominal pain, bleeding and weight loss and non-functional lung NET, if symptomatic, may present with cough, or coughing up blood, recurrent pulmonary infection, breathlessness and chest pain. Fifty per cent of patients are asymptomatic at diagnosis.^6,7,8,9

"Advanced NET can be a difficult cancer to diagnose with limited treatment options to date," said Dr. Simron Singh, medical oncologist and co-director of the multidisciplinary specialized neuroendocrine clinic at the Sunnybrook Odette Cancer Center in Toronto. "It is encouraging and very useful for us to have a new treatment approved for those of GI or lung origin."

At the time of diagnosis, 5%-44% (depending on site of tumour origin) of patients with NET in the GI tract and 28% of patients with lung NET have distant disease, meaning the cancer has spread to other areas of the body, making it difficult to treat.^1,10 Progression, or the continued growth or spread of the tumour, is typically associated with poor outcomes.¹¹

The prevalence of neuroendocrine tumours (NET) is estimated at 35 per 100,000 but may be considerably higher if undiagnosed tumours are included. Of the approximately 12,000 to 15,000 Canadians with NET, only 10 per cent have a complete and accurate diagnosis.¹²

"Canadian NET patients are in great need of new therapies to give them hope and this approval is a very positive step forward," said Jacqueline Herman, President and Director of Treatment Access & Health Policy of CNETS (Carcinoid-NeuroEndocrine Tumour Society) Canada. "NET can be difficult to diagnose but progress very rapidly so patients can't wait. We hope our provincial cancer agencies and drug plans will recognize this urgent need by ensuring patients who could benefit will soon have access to AFINITOR^® for these conditions."

The annual incidence of clinically significant NET is approximately 2.5 to 5 per 100,000 but this is rising. NET is now the fastest growing class of cancers worldwide, accounting for approximately 2% of cancers.¹²

This Health Canada approval of AFINITOR^® is based on results from RADIANT-4, a randomized, controlled phase III study which examined the efficacy and safety of AFINITOR^® plus best supportive care (BSC) compared to placebo plus BSC in patients with advanced non-functional NET of GI or lung origin.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by words such as "hope," "will," "as soon as possible," "expected," or similar terms, or by express or implied discussions regarding potential additional marketing approvals or new indications or labeling for AFINITOR^® or regarding potential future revenues from AFINITOR^®. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management 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 AFINITOR^® will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that AFINITOR^® will be submitted or approved for sale in any additional markets or at any particular time. Nor can there be any guarantee that AFINITOR^® will be commercially successful in the future, or will achieve any particular level of revenue. In particular, management's expectations regarding AFINITOR^® could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures and reimbursement issues; unexpected safety issues; unexpected manufacturing issues, 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 Novartis Pharmaceuticals Canada Inc.
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. In 2015, the company invested $53 million in research and development in Canada. Located in Dorval, Quebec, Novartis Pharmaceuticals Canada Inc. employs more than 700 people in Canada and is an affiliate of Novartis AG, which provides innovative healthcare solutions that address the evolving needs of patients and societies. For further information, please consult www.novartis.ca. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2015, the Group achieved net sales of USD 49.4 billion, while R&D throughout the Group amounted to approximately USD 8.9 billion (USD 8.7 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 119,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit http://www.novartis.com.

AFINITOR^® is a registered trademark

References:  
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¹ American Cancer Society. Gastrointestinal Carcinoid Tumors. Available at http://www.cancer.org/acs/groups/cid/documents/webcontent/003102-pdf.pdf. Accessed February 2016
² American Cancer Society. Lung Carcinoid Tumors. Available at http://www.cancer.org/acs/groups/cid/documents/webcontent/003117-pdf.pdf. Accessed February 2016
³ Novartis Pharmaceuticals Canada Inc., AFINITOR^® (everolimus) Product Monograph, May 16, 2016, p. 1.
⁴ Canadian Cancer Society, What is neuroendocrine cancer?, accessed May 27, 2016 at: http://www.cancer.ca/en/cancer-information/cancer-type/neuroendocrine/neuroendocrine-cancer/?region=qc 
⁵ Choti, M.A., et al. Prevalence of functional tumors in neuroendocrine carcinoma: An analysis from the National Comprehensive Cancer Network Neuroendocrine Tumors database. The North American Neuroendocrine Tumor Society (NANETS) Symposium. October 2012, San Diego, US
⁶ Öberg K, et al. Gastrointestinal neuroendocrine tumors. Annals of Oncology. 2010; 21: vii72–vii80.
⁷ Modlin I, et al. Priorities for improving the management of gastroenteropancreatic neuroendocrine tumors. J Natl Cancer Inst. 2008; 100: 1282-1289.
⁸ Modlin I, et al. Current status of gastrointestinal carcinoids. Gastroenterology. 2005; 128: 1717-1751.
⁹  Wolin EM. Challenges in the diagnosis and management of well-differentiated neuroendocrine tumors of the lung (typical and atypical carcinoid): Current status and future considerations. The Oncologist. 2015; 20:1123-1131.
¹⁰ Yao J, 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: 3063-72.
¹¹ National Cancer Institute. "NCI Dictionary of Cancer Terms" available at http://www.cancer.gov/publications/dictionaries/cancer-terms. Accessed February 2016
¹² CNETS Canada, Neuroendocrine Tumours Overview, Incidence/Prevalence, accessed May 26, 2016 at: http://cnetscanada.org/patients-caregivers/resources/489-2/

SOURCE Novartis Pharmaceuticals Canada Inc.

Novartis Media Relations: Daphne Weatherby, Novartis Pharma Communications, [phone], [email protected]; [phone], [email protected]