XALKORI® Approved by Health Canada for the Treatment of Patients with ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

First Health Canada-Approved Treatment for Canadians with ROS1 NSCLC

KIRKLAND, QC, Nov. 14, 2017 /CNW/ - Pfizer Canada announced that Health Canada has expanded the indication of XALKORI^® (crizotinib) to include its use as a monotherapy in the treatment of patients with ROS1-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC).¹ XALKORI was previously approved by Health Canada as a monotherapy for use in patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic NSCLC.¹

"Often, lung cancer is diagnosed in the late stages of the disease, which means patients face considerable challenges, including timely access to innovative treatments," says Dr. Rosalyn Juergens, Medical Oncologist and Board Member of Lung Cancer Canada. "With this expanded indication, patients living with ROS1-positive metastatic non-small cell lung cancer in Canada now have their first approved treatment option."

Excluding non-melanoma skin cancers, lung cancer is the most common cancer in Canada and is the leading cause of cancer death in both men and women.² In 2017 alone, an estimated 28,600 Canadians will be diagnosed with the disease, including 80-85% of which will be diagnosed as NSCLC.^2,3 Of those diagnosed with NSCLC, approximately 1-2% are ROS1-positive.⁴

"The last decade has witnessed the dramatic coming of age of targeted therapy in lung cancer," says Dr. Ming-Sound Tsao, Professor of Laboratory Medicine and Pathobiology, University of Toronto. "Precision medicines allow patients' treatment plans to be tailored based on the genetic make-up of their cancer. The field of precision medicine is still developing, and the discovery of ROS1 and availability of new targeted medicines have helped to advance the understanding of how to treat what were previously unknown genetic/molecular aberrations."

The Health Canada approval of this expanded indication is based on the final results of Study A8081001, a multicenter, multinational, single-arm Phase 1 study that included 53 patients with ROS1-positive advanced NSCLC treated orally with XALKORI 250 mg twice daily. The primary efficacy outcome measures in this study were objective response rate and duration of response.

"Pfizer Canada is proud to bring XALKORI to Canadians living with ROS1-positive metastatic NSCLC," says John Leasure, Pfizer Oncology Canada Lead. "XALKORI is the first treatment approved for ROS1 NSCLC in Canada and this milestone demonstrates our unwavering commitment to provide innovative medicines to patients that need them most."

In Canada and the United States, XALKORI is co-promoted by Pfizer and EMD Serono.

About Pfizer Canada Inc.
Pfizer Canada Inc. is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical companies. Our diversified health care portfolio includes some of the world's best known and most prescribed medicines and vaccines. Historically, Pfizer Inc. has invested more than US $7 billion toward developing safe and effective medicines. At Pfizer, we're working together for a healthier world. To learn more about Pfizer Canada, visit pfizer.ca or you can follow us on Twitter (twitter.com/PfizerCA) or Facebook (facebook.com/PfizerCanada).

About EMD Serono, Canada
EMD Serono, Canada, is the Canadian biopharmaceutical business of Merck KGaA, Darmstadt, Germany. EMD Serono, Canada has integrated cutting-edge science, innovative products and devices, and industry-leading patient support and access programs. EMD Serono, Canada has deep expertise in neurology, fertility and endocrinology, as well as a robust pipeline of potential therapies in neurology, oncology, immunology and immuno-oncology. Today, EMD Serono, Canada has more than 100 employees across Canada with headquarters in Mississauga, Ontario.

About Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck KGaA, Darmstadt, Germany generated sales of € 15.0 billion in 66 countries.

Founded in 1668, Merck KGaA, Darmstadt, Germany, is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck KGaA, Darmstadt, Germany, holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, Millipore Sigma and EMD Performance Materials.

References:

1.	XALKORI Product Monograph. Pfizer Canada Inc., August 25, 2017.
2.	Canadian Cancer Society. Lung Cancer Statistics. Available at: http://www.cancer.ca/en/cancer-information/cancer-type/lung/statistics/?region=on. Accessed September 15, 2017.
3.	Canadian Cancer Society. Cancerous Tumours of the Lung. Available at: http://www.cancer.ca/en/cancer-information/cancer-type/lung/lung-cancer/cancerous-tumours/?region=on. Accessed October 3, 2017.
4.	Bubendorf L, et al. Testing for ROS1 in non-small cell lung cancer: a review with recommendations. Virchows Arch. 2016 Nov;469(5):489-503. Epub 2016 Aug 17.

SOURCE Pfizer Canada Inc.

Manon Genin, Pfizer Canada Inc., 1-866-9PFIZER (973-4937), [email protected]; Shikha Virdi, EMD Serono, Canada, 416-561-6276, [email protected]