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Health Canada Approves New Cream Treatment, Aldara (Imiquimod) for Basal Cell Carcinoma

TORONTO, ON -- January 6, 2005 -- Health Canada has approved Aldara™ (imiquimod) Cream, 5%, a topical prescription medication for the treatment of superficial basal cell carcinoma (sBCC) - a form of non-melanoma skin cancer. Aldara is the first new treatment for this type of cancer to be approved in Canada in close to 30 years and is the first in a new class of medications called immune response modifiers. The medication works by triggering the body's immune system to find and kill mutated cells on the outer layer of the skin.

"Standard skin cancer treatment options include scraping, burning, radiation, or surgically removing cancer lesions from the skin, which can be uncomfortable and sometimes disfiguring," says Dr. Goldstein, consultant dermatologist at the University Health Network, Toronto Western Hospital. "But with the availability of Aldara for sBCC, Canadians have another effective option, which is associated with little or no discomfort, and may not cause the long-term scarring that can be seen with more invasive treatments. This therapy can replace surgical options for superficial BCCs, with good cure rates and an acceptable side effect profile."

Skin cancer is the most common of all cancers affecting approximately 82,000 Canadians(1). Over the last 15 years its incidence has increased by two-thirds (67 per cent)(2). Basal cell carcinoma accounts for 80 per cent of all skin cancers(3).

"When I was diagnosed with basal cell carcinoma (BCC), I was shocked - skin cancer was never something I was concerned about," says Canadian Hall of Fame and Senior PGA Championship golfer, David Barr. "Now I know the importance of examining my skin regularly and seeing my doctor if I notice anything unusual. For many of us the damage from years of sun exposure is already done, so early detection is crucial. If caught early, BCC is highly treatable."

Aldara is a cream that is applied at home by the patient and unlike most approved therapies, is non-invasive, which means it does not involve surgery. In clinical trials involving 364 patients with primary sBCCs, 82 per cent of patients treated with Aldara achieved complete disease clearance confirmed by biopsy, compared with only three per cent in the placebo group(4).

"Finding effective and patient-friendly options is important in advancing the treatment of non-melanoma skin cancer," comments Dr. Jason Rivers, dermatologist and active staff member at the British Columbia Cancer Agency, and professor of dermatology at the University of British Columbia in Vancouver. "Not only is Aldara effective, but it's exciting because it works with the body's own immune system to fight cancer from within, rather than treating it invasively from the outside."

Aldara is applied five times per week, for six weeks, to sBCC lesions with a maximum diameter of two centimetres, confirmed by biopsy, located on the trunk of the body, neck, or extremities (excluding hands and feet). In clinical trials, the most frequent reactions reported by Aldara patients were local skin reactions, including erythema (redness), and scabbing at the application site. Although 97 per cent of patients reported erythema, only three per cent reported pain and only one per cent of patients discontinued treatment due to local skin or application-site reactions. Scarring was not reported as a result of Aldara treatment at the 12 week post-treatment evaluation.

Aldara was first approved by Health Canada in 1999 for the treatment of external genital and perianal warts, caused by the human papillomavirus (HPV). In June 2004, Health Canada approved Aldara for the treatment of actinic keratosis, a precancerous skin condition that can lead to squamous cell carcinoma, another form of non-melanoma skin cancer.

Basal Cell Carcinoma
Basal cell carcinoma affects approximately 65,000 Canadians(5). Superficial BCC is a type of BCC that typically occurs on the torso and may appear on the face. It appears as well-defined, red, scaly patches that can resemble eczema or psoriasis. Like other skin cancers, sBCC is caused by over exposure to the sun's damaging rays. Basal cell carcinoma lesions generally grow slowly and have up to a 95 per cent treatment success rate if caught early(6). If left untreated, BCC tumours can continue to grow, eventually invading and causing damage to surrounding tissues.


3M and Aldara are trademarks of 3M. Used under license in Canada.

References:
(1) National Cancer Institute of Canada: Canadian Cancer Statistics 2004.
(2) Ibid.
(3) Alam M, Datner D. Cutaneous squamous cell carcinoma. New Eng J Med. 2001; 334 (13): 975-983
(4) Geisse et.al. Imiquimod 5% cream for the treatment of superficial basal cell carcinoma: Results from two phase III, randomized, vehicle-controlled studies. J. Amer. Acad. Dermatol. May 2004: 722-733.
(5) National Cancer Institute of Canada: Canadian Cancer Statistics 2004.
(6) American Accreditation HealthCare Commission for Medline Plus Medical Encyclopedia: Basal cell carcinoma. Available at http://www.nlm.nih.gov/medlineplus/ency/article/000824.htm (Accessed October 19, 2004).


SOURCE: 3M Canada

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