New therapeutic option now available for select treatment resistant lung cancer patients

• On average, 72 Canadians will be diagnosed with lung cancer every day¹; non-small cell lung cancer is the most common form of lung cancer² making up 85 to 90 per cent of all cases³
• Of those, approximately 2 to 7 per cent are diagnosed with ALK+ non-small cell lung cancer⁴, a form of the cancer that typically affects younger patients with no history of smoking⁵
• ^PrZykadia™ targets the anaplastic lymphoma kinase positive (ALK+) genetic mutation⁶

DORVAL, QC, April 7, 2015 /CNW Telbec/ - Novartis Pharmaceuticals Canada Inc. (Novartis) is pleased to announce that Health Canada has issued a marketing authorization with conditions for Zykadia™ (ceritinib), a lung cancer treatment that addresses an unmet medical need for patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have progressed on or who were intolerant to crizotinib⁷.

"The majority of ALK+ patients are younger and have never smoked, which represents a demographic that many are surprised to hear associated with this devastating illness. Until recently, treatment options have been limited." states Dr. Jeffrey Rothenstein, MD, FRCPC. "Zykadia represents an important new option for patients who relapse after starting initial therapy."

NSCLC can be characterized based on a patient's genetic abnormalities that are causing the cancer growth and researchers have identified over 12 of these genetic abnormalities⁸. Of those, 2 to 7 per cent are driven by a rearrangement of the ALK gene, which increases the growth of cancer cells and can be identified by a molecular test of the cancer tumor⁹.

"Developments in targeted gene therapy such as treatments targeting ALK rearrangements are helping us move towards personalized medicine," states Shem Singh, Executive Director, Lung Cancer Canada. "Molecular testing should be done on a patient's tumour as soon as there is a NSCLC lung cancer diagnosis. This will help patients and physicians identify the best treatment as quickly as possible."

The marketing authorization with conditions for Zykadia™ was based on a pivotal Phase 1 trial that included 163 patients with metastatic ALK+ NSCLC who had received prior treatment with crizotinib.  Among these patients, Zykadia™ achieved an overall response rate of 54.6% and the median duration of response was 7.4 months¹⁰.

"Novartis is committed to ongoing research in the area of lung cancer with the goal of developing new medicines to help improve the lives of cancer patients and their families. We are proud to be at the forefront of innovative research into personalized treatments that may help bring new solutions to more patients," said Fionnuala Doyle, General Manager, Oncology, Novartis Pharmaceuticals Canada Inc.

About Zykadia™
Zykadia™ (ceritinib) is indicated as monotherapy for use in patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have progressed on or who were intolerant to crizotinib.

Marketing authorization with conditions was based on a primary efficacy endpoint of overall response rate (ORR) as well as duration of response (DR) in clinical Study CLDK378X2101, based on investigator assessment using RECIST. There are no available data demonstrating improvement in survival or quality of life with Zykadia^TM.

In order to receive Zykadia™, patients must have a documented ALK-positive status for locally advanced or metastatic NSCLC based on a validated ALK assay.¹¹

Based on the integrated safety database of 255 patients (246 ALK-positive NSCLC patients and nine non-NSCLC patients) treated at the recommended dose of 750 mg of Zykadia™, serious warnings and precautions include QT interval prolongation and Interstitial Lung Disease/Pneumonitis including fatal cases. Zykadia™ has not been studied in patients with hepatic impairment or severe renal impairment requiring peritoneal dialysis or hemodialysis, hepatotoxicity and gastrointestinal toxicity. Zykadia™ (ceritinib) should only be prescribed and supervised by a qualified physician experienced in the use of anticancer agents.

The majority of Zykadia™ treated patients experienced adverse drug reactions. Diarrhea, nausea, vomiting, abdominal pain, fatigue, alanine aminotransferase (ALT) increased, decreased appetite, aspartate aminotransferase (AST) increased, constipation, neuropathy, esophageal disorder, rash and blood creatinine increased were the most common adverse drug reactions (experienced by at least 10% of the patients).  For further details, see the Zykadia™ Product Monograph.

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 2012, the company invested close to $100 million in research and development in Canada. Novartis Pharmaceuticals Canada Inc. employs more than 600 people in Canada. For further information, please consult www.novartis.ca.

About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2014, the Group achieved net sales of USD 58 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). As of December 31, 2014 Novartis Group companies employed approximately 133,000 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.

References
^1	Canadian Lung Association, http://www.cancer.ca/en/cancer-information/cancer-type/lung/statistics/?region=on.   Accessed on February 13, 2014
^2	Public Health Agency of Canada : http://www.phac-aspc.gc.ca/cd-mc/cancer/lung_cancer-cancer_poumon-eng.php, Accessed February 13, 2014
^3	American Cancer Society: Lung Cancer – Non-Small Cell Detailed Guide. Available at: http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-what-is-non-small-cell-lung-cancer . Accessed on February 13, 2015.
^4	Canadian Lung Association, http://www.cancer.ca/en/cancer-information/cancer-type/lung/statistics/?region=on.   Accessed on February 13, 2014
^5	Couraud, S. et al. No impact of passive smoke on the somatic profile of lung cancers in never-smokers. European Respirology Journal, 2015: 1-11
^6	Zykadia Product Monograph, March 26,   2015, page 11.
^7	Zykadia Product Monograph, March 26, 2015, page 1.
^8	Riess JW, Wakelee, HA. Metastatic Non-Small Cell Lung Cancer Management: Novel Targets and Recent Clinical Advances. Clinical Advances in Hematology & Oncology. 2012; 10: 226-224.
^9	National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Non-Small Cell Lung Cancer. NCCN 2014 3:1-148.
^10	Zykadia Product Monograph, March 26,   2015, page 11.
^11	Ibid.

Zykadia is a trademark.

SOURCE NOVARTIS PHARMACEUTICALS CANADA INC.

Novartis Media Relations: Andrea Gilpin, Novartis Pharmaceuticals Canada Inc., 514 633-7873, [email protected]; Stephanie Lyttle, National Public Relations, 514-501-8685, [email protected]