Roche’s Erivedge receives approval in Switzerland for the treatment of adults with advanced basal cell carcinoma

A novel agent shrinks disfiguring lesions caused by basal cell carcinoma. First-time approval of Erivedge in Europe

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Erivedge has been approved by the Swiss agency for the authorisation and supervision of therapeutic products (Swissmedic) for the treatment of basal cell carcinoma (BCC). Erivedge can be used in adult patients in whom BCC has spread to other parts of the body (metastasised), returned after surgery or is no longer treatable with surgery or radiation1. Erivedge is a novel, targeted agent that inhibits the hedgehog signalling pathway, which is activated in over 90% of BCC patients.

“The occurrence of inoperable, locally advanced or metastatic basal cell carcinoma can be severely disfiguring and life-threatening to patients,” according to Professor Reinhard Dummer, who heads the skin cancer centre at the University Hospital Zurich. “A conspicuous tumour, generally in the head area, is very stressful to patients. Such disfiguring lesions significantly impair their quality of life and often result in their social isolation. Erivedge is the first effective medical treatment alternative."

Basal cell carcinoma occurs most frequently on the head, neck, arms, and other areas of skin exposed to the sun. While BCC tumours are generally characterised by slow growth and minimal soft tissue invasiveness2, they may damage surrounding tissue, cartilage and bones as they advance, potentially causing considerable tissue destruction and disfiguration 3.

About basal cell carcinoma

Basal cell carcinoma (BCC) is the most common type of skin cancer in Europe5, Australia6 and the United States4. More than two million new cases worldwide are reported annually7. An estimated 10,300 people a year are diagnosed with basal cell carcinoma in Switzerland8.

In most cases, basal cell carcinoma is curable, particularly if the cancer is still restricted to a small area of the skin. In this stadium, surgical removal is the best treatment option. If the disease is left untreated or recurs after surgery, it may advance further and invade surrounding areas such as sensory organs (ears, nose and eyes), bone, or other tissues3,9,10. Inoperable, locally advanced basal cell carcinoma is a serious problem. No effective treatment options existed for such patients up to now4. The clinical symptoms of BCC patients often include open, bleeding, scab-forming sores that may be infected with bacteria and therefore emit an unpleasant odour. Such symptoms significantly impair patients’ quality of life and frequently result in their stigmatisation and social isolation.

In a small proportion of patients, untreated basal cell carcinoma may continue to advance over the years and spread throughout the body (0.0028% to 0.55% of diagnosed BCC cases progress to metastatic BBC)11,12. Locally advanced basal cell carcinoma (laBCC) and metastatic basal cell carcinoma (mBCC) are referred to collectively as advanced basal cell carcinoma (aBCC). Advanced basal cell carcinoma is very rare; the annual number of such patients in Switzerland is estimated at 20 to 40.

Risk factors for basal cell carcinoma

The average lifetime risk for Caucasians of developing BCC is around 30%13. BCC is more common in men than in women, with a ratio of approximately 2:114. Exposure to ultraviolet radiation (UV), which results in cumulative DNA damage and genetic mutations, is a leading cause of BCC. The following risk factors also contribute to the development of BCC13,15:

  • Skin type 1 (i.e., always burns, never tans)
  • Red or blond hair
  • Blue or green eyes
  • Freckles in childhood
  • Sunburn in childhood
  • A family history of skin cancer
  • Immunosuppressive therapy
  • Ingestion of arsenic
  • Moreover, patients who have already contracted BCC are at greater risk of developing further cases of BCC13.

    Pivotal study: ERIVANCE BCC/SHH4476g

    ERIVANCE BCC/SHH4476g is a global, single-arm, Phase II study investigating efficacy and safety. It is referred to as a single-arm study because Erivedge is a first-in-class drug for the treatment of a disease for which no effective therapy previously existed, and a cross-comparison of Erivedge with other treatment methods is therefore not possible. Treatment with Erivedge can achieve the following clinical benefits:

  • In 94% of patients with mBCC and in 82% of patients with laBCC, Erivedge can shrink tumours or at least stabilise disease16.
  • 54% of patients with laBCC have a histopathological response within 24 weeks, with no indication of residual basal cell carcinoma17.
  • 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, infectious diseases, inflammation, metabolism and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2012, Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

    All trademarks used or mentioned are protected by law.

    References
    1 Drug prescribing information at www.swissmedicinfo.ch
    2 Walling HW, Fosko SW, Geraminejad PA, et al. Aggressive basal cell carcinoma: presentation, pathogenesis, and management. Cancer Metastasis Rev. Aug-Dec 2004; 23(3-4):389-402
    3 National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™). Basal cell and squamous cell skin cancers. Version 2.2012
    4 Von Hoff DD, LoRusso PM, Rudin CH et al. Inhibition of the hedgehog pathway in advanced basal-cell carcinoma. N Engl J Med. Sep 2009;361(12):1164-1172
    5 Telfer NR, Colver GB and Morton CA. Guidelines for the management of basal cell carcinoma. Br J Dermatol. Jul 2008;159(1):35-48
    6 Gilbody JS, Aitken J, Grenn A. What causes basal cell carcinoma to be the commonest cancer? Aust J Public Health. Jun1994; 18(2):218-21
    7 Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin. Sep-Oct 2010; 60 (5):277–300
    8 Krebsliga Schweiz, Broschüre “Heller Hautkrebs: Basaliom, Spinaliom, Vorstufen”, 2008
    9 Von Domarus H, Stevens PJ. Metastatic basal cell carcinoma. Report of five cases and review of 170 cases in the literature. J Am Acad Dermatol. Jun 1984;10(6):1043-1060
    10 Mosterd K, Arits AH, Thissen MR, Kelleners-Smeets NW. Histology-based treatment of basal cell carcinoma. Acta Derm Venereol. 2009;89(5):454-458
    11 Wadhera A, Fazio M, Bricca G, Stanton O. Metastatic basal cell carcinoma: a case report and literature review. How accurate is our incidence data? Dermatol Online J. Sep 2006;12(5):7
    12 Ting PT, Kasper R, Arlette JP. Metastatic basal cell carcinoma: report of two cases and literature review. J Cutan Med Surg. Jan 2005;9(1):10-15
    13 Wong CS, Strange RC, Lear JT. Basal cell carcinoma. BMJ. Oct 2003;327(7418):794-798.
    14 Roewert-Huber J, Lange-Asschenfeldt B, Stockfleth E, Kerl H. Epidemiology and aetiology of basal cell carcinoma. Br J Dermatol. Dec 2007;157 Suppl 2:47-51.
    15 Rubin AI, Chen EH, Ratner D. Basal-cell carcinoma. N Engl J Med. Nov 2005;353(21):2262-2269.
    16 Sekulic A, Migden MR, Oro AE, et al. Efficacy and safety of vismodegib in advanced basal cell carcinoma (BCC): 12-month update of the ERIVANCE BCC study, ESMO Sep/Oct 2012, Poster 1112PD
    17 Sekulic A, Migden MR, Oro AE, et al., Efficacy and safety of vismodegib in advanced basal-cell
    18 carcinoma. N Engl J Med. Jun2012; 366 (23): 2171-9

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