Nexavar® (sorafenib tablets) now Approved in Canada for the Treatment of Differentiated Thyroid Cancer

• Nexavar is the only approved treatment for patients with RAI-refractory differentiated thyroid cancer
• Nexavar significantly extended progression-free survival in patients with RAI-refractory differentiated thyroid cancer compared to placebo in the Phase III DECISION trial

TORONTO, July 7, 2014 /CNW/ - Bayer Inc. is pleased to announce the Health Canada approval of Nexavar for the treatment of patients with locally advanced or metastatic, progressive, differentiated thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).

The approval is based on data from the Phase III DECISION (stuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine refractory thyrOid caNcer) trial. In the trial, sorafenib significantly extended progression-free survival (PFS), the primary endpoint of the study, compared to placebo (HR=0.59 [95% CI, 0.45-0.76]; p<0.0001), which represents a 41 percent reduction in the risk of disease progression or death for patients who received sorafenib compared to placebo-treated patients. The median PFS was 10.8 months in patients treated with sorafenib, compared to 5.8 months in patients receiving placebo.

The safety and tolerability profile of sorafenib in patients in the trial was generally consistent with the known profile of sorafenib. The most common treatment-emergent adverse events in the sorafenib arm were hand-foot skin reaction, diarrhea, alopecia, weight loss, fatigue, hypertension and rash. Results from the trial were presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2013 and published in The Lancet in April 2014.

About Thyroid Cancer
Thyroid cancer is the most common endocrine malignancy¹. There are more than 298,000 new cases of thyroid cancer annually and nearly 40,000 people die from thyroid cancer worldwide each year.² In 2014, it is estimated that 6,000 Canadians will be diagnosed with thyroid cancer.³

Papillary, follicular (including Hürthle cell) and poorly differentiated types of thyroid cancer are classified as "differentiated thyroid cancer" and account for approximately 94 percent of all thyroid cancers.⁴ While the majority of differentiated thyroid cancers are treatable, RAI-refractory locally advanced or metastatic disease is more difficult to treat and is associated with a lower patient survival rate.

About Nexavar^® (sorafenib tablets)
Nexavar® (sorafenib tablets), an oral anti-cancer therapy, is currently approved in more than 100 countries worldwide. In Canada, it is approved for the treatment of hepatocellular carcinoma (HCC) and for the treatment of patients with advanced renal cell carcinoma (RCC) who have failed or are intolerant to prior systemic therapy⁵. Nexavar is also now approved in Canada for the treatment of patients with locally advanced or metastatic, progressive differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).

In preclinical studies, Nexavar has been shown to inhibit multiple kinases thought to be involved in both cell proliferation (growth) and angiogenesis (blood supply) - two important processes that enable cancer growth. These kinases include Raf kinase (C-CRAF, BRAF, mutant BRAF), VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3, RET-DTC and RET.

Nexavar is also being evaluated by Bayer and Onyx, international study groups, government agencies and individual investigators in a range of other cancers.

Nexavar is co-developed by Onyx Pharmaceuticals, Inc., an Amgen subsidiary, and Bayer, except in Japan where Bayer manages all development. The companies co-promote Nexavar in the U.S. Outside of the U.S. Bayer has exclusive marketing rights, and Bayer and Onyx share profits globally, excluding Japan.

About Oncology at Bayer
Bayer is committed to delivering Science for a Better Life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now includes three oncology products and several other compounds in various stages of clinical development. Together, these products reflect the company's approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

About Bayer Inc.
Bayer Inc. is a Canadian subsidiary of Bayer AG and the corporate headquarters for the Canadian operations.  Founded in 1863, Bayer AG is an international research-based group with core businesses in healthcare, crop science and innovative materials committed to creating a better life for all through science.

In Canada, Bayer operates its healthcare business - Pharmaceuticals, Consumer Care, Diabetes Care, Animal Health and Radiology & Interventional - from its headquarters in Toronto, ON, and Bayer CropScience Inc. operates out of its head office in Calgary, AB. Together with its material science business, Bayer improves the quality of life for Canadians through products that fight disease, protect crops and animals, and provide high-performance materials for numerous daily life uses.

With more than 1,300 employees across the country, in 2013, Bayer had sales of $1.6 billion and invested $61 million in research and development in Canada. Globally, Bayer AG had sales of €40.2 billion and invested €3.2 billion in research and development.

For more information about Bayer, please visit www.bayer.ca.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

---

¹ National Cancer Institute. "General Information about Thyroid Cancer." http://www.cancer.gov/cancertopics/pdq/treatment/thyroid/healthprofessional.

² World Health Organization: GLOBOCAN 2012. Cancer Incidence and Mortality Worldwide in 2012. http://globocan.iarc.fr/Pages/fact_sheets_population.aspx

³ Canadian Cancer Society http://www.cancer.ca/en/cancer-information/cancer-type/thyroid/statistics/?region=on

⁴ Naifa Lamki Busaidy and Maria E. Cabanillas, "Differentiated Thyroid Cancer: Management of Patients with Radioiodine Nonresponsive Disease," Journal of Thyroid Research, vol. 2012

⁵ Nexavar Product Monograph, June 30, 2014

 

 

SOURCE: Bayer Inc.

For further information:

Contact:
Emily Hanft
[e-mail] / [phone]