First treatment for advanced forms of most common cancer approved by Health Canada

Erivedge™ (vismodegib) is a First-in-Class Treatment That Helps Shrink Disfiguring or Potentially Life-Threatening Lesions in Advanced Form of Skin Cancer

MISSISSAUGA, ON, Aug. 27, 2013 /CNW/ - Erivedge™ (vismodegib) was recently approved in Canada for the treatment of adult patients with histologically confirmed metastatic basal cell carcinoma or locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy. Basal cell carcinoma (BCC) is the most common type of cancer^i,ii and accounts for 80 per cent of all skin cancer cases.ⁱ If left untreated, BCC can progress to more advanced stages resulting in severe deformities and debilitating effects,ⁱⁱⁱ and can even lead to death.^iv When BCC progresses to an advanced state, surgical and non-surgical treatments are not effective or suitable,^{v, vi} which, up until now, has left this patient population with no treatment options.

"Previously, there were limited medical therapies available to treat this rare and potentially life-threatening disease," says Dr. Marni C. Wiseman, Dermatologist. "Advanced BCCs are often open lesions that may bleed, become infected, and may be associated with unpleasant odours, resulting in both stigmatization and social isolation for patients. The approval of Erivedge™ offers new hope for Canadians living with this devastating disease and gives their health care providers a new treatment option for advanced BCC management."

Murray Thorimbert of Whitby, Ontario, has lived with advanced BCC for almost 35 years. Murray received Erivedge™ as part of a clinical trial.

"Since my early 20s, I have had six to seven surgeries each year to remove BCCs - I even had part of my scalp removed - but the lesions just kept coming back," says Thorimbert. "The continual procedures took a serious toll on me and my family. Since I started taking Erivedge, my lesions started to clear up and I felt like I started to get my life back. I haven't had a single surgery since."

About Advanced BCC
BCC affects as many as 60,000 Canadians each year,^vii and it is estimated that one per cent of all BCC cases will progress^viii,ix to advanced BCC and either invade the surrounding tissue (locally advanced) or spread to other parts of the body (metastasized).^x,xi Patients whose disease has spread to the surrounding tissue may require the removal of key sensory organs such as the eye, ear or nose to control the disease,^xii,xiii while those whose disease has metastasized will have a median survival of just eight to 10 months.^xiv,xv

"When BCC goes untreated and turns into advanced BCC, the consequences of the disease can be devastating, and even fatal," says Kathy Barnard, Founder, Save Your Skin Foundation, and skin cancer survivor. "Although the medical consequences of advanced BCC are very serious, the embarrassment and social isolation associated with the disease sometimes prevents patients from seeking treatment. The approval of Erivedge gives patients with advanced BCC an effective treatment option, which can give them the courage to come forward, contribute to society and live fulsome, productive lives."

About Erivedge™
Erivedge™ is the first and only Health Canada-approved medicine to treat advanced BCC. It is a once-daily oral medication indicated for adults with BCC that has become advanced - either spread to other parts of the body or that is locally invasive and cannot be treated by surgery or radiotherapy.^xvi

"Until now, the spread of advanced BCC lesions to surrounding tissue has meant invasive, often disfiguring surgery, as well as devastating impacts to patients' health and quality of life," says Annette Cyr, Chair, Melanoma Network of Canada. "As someone who has experienced skin cancer first-hand, I know that the approval of Erivedge can have a profound impact on Canadians living with advanced BCC, who until now, have had no treatment options available to them."

For more information about advanced BCC and its treatment, speak to your doctor or visit www.saveyourskin.ca  or www.melanomanetwork.ca.

About Basal Cell Carcinoma and the Hedgehog Signaling Pathway
BCC is the most common type of cancer,^i,ii affecting as many as 60,000 Canadians each year.^vii It occurs most frequently on the head, neck, back, chest or shoulders, and other areas of skin exposed to the sun.^xvii

If BCC is left untreated or recurs in the same location after surgery or radiotherapy, it can become advanced BCC and may grow further into surrounding areas such as sensory organs (ears, nose and eyes), bone or other tissues. Depending on the location of the lesion, some cases of advanced BCC can be severely deforming, and treatment with surgery or radiation can lead to the loss of sensory organs and their functions such as eyesight or hearing.^xii,xiii

The Hedgehog signaling pathway normally plays an important role in regulating proper growth and development in the early stages of life. In some people, malfunctions occur causing the Hedgehog signaling pathway to be reactivated or to work incorrectly. Such abnormal activation of the Hedgehog signaling pathway plays an important role in the development of certain types of cancer, including BCC.^xviii,xix,xx Abnormal Hedgehog signaling is implicated in more than 90 per cent of BCC cases.^{xxi,xxii,xxiii}

Erivedge™ Efficacy in Advanced Basal Cell Carcinoma
The Health Canada approval of Erivedge™ is based on results from ERIVANCE BCC (SHH4476g), a pivotal international, single-arm, multi-centre, two-cohort, open-label, Phase II study that enrolled 104 patients with advanced BCC, including locally advanced BCC (71) and metastatic BCC (33).^xxiv

The ERIVANCE study showed Erivedge™ shrank lesions (objective response rate, or ORR) in 43 per cent (27/63) of patients with locally advanced BCC and 30 per cent of patients (10/33) with metastatic BCC, as assessed by independent review, the primary endpoint of the study. In the most recent analysis, the median duration of response was 7.6 months.^xxiv

Patients with locally advanced BCC had lesions that recurred after surgery, were not candidates for surgery (inoperable, or for whom surgery would result in substantial deformity), recurred after radiotherapy, or were not candidates for radiotherapy (radiotherapy was contraindicated or inappropriate). Study participants received 150 mg of Erivedge™ orally, once-daily, until disease progression or unacceptable toxicity.

Data from a global safety study, STEVIE, confirms the safety of Erivedge™ as a first-in-class Hedgehog pathway inhibitor in patients with advanced BCC.^xxv STEVIE enrolled 44 Canadian patients in six different cities, including Quebec City, Montreal, Toronto, London, Winnipeg and Edmonton.

About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan.  Roche Canada was founded in 1931. The company employs approximately 900 people across the country, with its pharmaceuticals head office located in Mississauga, Ontario and diagnostics division based in Laval, Quebec. Roche Canada is actively involved in local communities, investing in charitable organizations and partnering with healthcare institutions across the country. For more information, visit www.rochecanada.com.

Roche is dedicated to improving the health, survival and quality of life of skin cancer patients through its expanding skin cancer portfolio. Erivedge™ is the second Roche therapy approved for use in advanced skin cancer patients. In 2012, Zelboraf® was approved by Health Canada for the treatment of BRAF-positive metastatic melanoma.

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References
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ⁱⁱⁱ Erivedge. What is advanced BCC? Available at: http://www.erivedge.com/patient/advanced-bcc/. Accessed June 20, 2013.
^iv Skin Cancer Foundation. Basal Cell Carcinoma Treatment Options. Available at: http://www.skincancer.org/skin-cancer-information/basal-cell-carcinoma/bcc-treatment-options. Accessed June 27, 2013.
^v National Comprehensive Cancer Network: NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines TM). Basal cell and squamous cell skin cancers. Version 2.2012.
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^xxiv Sekulic, A., Midgen M.R., et. Al. Efficacy and safety of vismodegib in advanced basal-cell carcinoma. The New England Journal of Medicine. 2012. 366:23.
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SOURCE: Roche Canada

Candice Bruton
Edelman
416-849-8938
[email protected] 

Nancy Zorzi
Roche Canada
905-542-5555 ext. 4227
[email protected]