More than 197 000 patients are diagnosed each year with this cancer. When melanoma is caught and treated early, it is generally a curable disease.(1-2) However, if left untreated, melanoma can spread to other parts of the body, including the liver, lungs, bones, and brain. This is known as metastatic melanoma and is the deadliest and most aggressive form of skin cancer.(3-4)

Causes and risk factors

Melanoma develops in melanocyte cells, which are found in the outer layer of the skin. Melanocyte cells produce the pigment melanin, which gives color to the skin, hair, and eyes. Melanin protects the skin from ultraviolet (UV) rays found in sunlight. Exposure to UV rays causes melanocyte cells to increase melanin production, which makes the skin darker and appear sun-tanned. Excessive exposure to UV rays can cause mutations in the melanocyte cells.(5-6) Melanoma occurs when these mutations promote unregulated cell growth and proliferation, and tumor formation.


Prompt detection, diagnosis, and therapeutic intervention are critical for people with melanoma.(7) Melanoma that has not spread can usually be successfully treated with surgery.

Treatment approaches

Treatment options vary, depending on the severity or stage of the melanoma. Surgery is the main treatment option for melanoma that is restricted to a particular area of skin.(8) There is no cure for metastatic melanoma. Limited treatment options include some types of chemotherapy and immunotherapy.

Personalising treatment

Personalised Healthcare focuses on developing medicines that are tailored to the subgroup of patients carrying a specific cancer sub-type. As gene expression in melanoma has become better understood, the potential for Personalised Healthcare approaches has emerged.

In summer 2011 the US health authorities simultaneously approved a new oral, highly selective small molecule inhibitor of this specific oncogenic protein and its companion test. In late 2011 the drug and test were made available in Switzerland. In the EU the medicine was approved in February 2012.

This medicine is designed to target the active confirmation of this oncogenic protein, which in turn is expected to prevent activation of other proteins and thus inhibit down-stream signaling. This may inhibit cell proliferation and result in apoptosis, leading to tumor regression.

This is the first and only FDA-approved personalised medicine shown to improve survival in people with this specific mutation-positive metastatic melanoma and it shows the benefits of Roche’s Personalised Healthcare approach.

Clinical studies

Roche is pursuing a broad development program with this new treatment that includes combinations with other medicines (both approved and investigational, from Roche and other companies), as well as studies in other tumor types.

1) Leong SP. Future perspectives on malignant melanoma. Surg Clin North Am 2003;83(2):453-6.
2) Creagan ET. Malignant melanoma: an emerging and preventable medical catastrophe. Mayo Clin Proc 1997;72(6):570-4.
3) Algazi AP, et al. Treatment of cutaneous melanoma: current approaches and future prospects. Cancer Manag Res 2010;2:197-211.
4) Korn EL, et al. Meta-analysis of phase II cooperative group trials in metastatic stage IV melanoma to determine progression-free and overall survival benchmarks for future phase II trials. J Clin Oncol 2008;26(4):527-34.
5) Gallagher RP, et al. Ultraviolet radiation. Chronic Dis Can 2010;29 Suppl 1:51-68.
6) Soehnge H, et al. Mechanisms of induction of skin cancer by UV radiation. Front Biosci 1997;2:d538-51.
7) Tung, R. Vidimos, A. Melanoma. Accessed on: June 20, 2011
8) Dummer R, et al. Ann Oncol 2010;21(suppl 5):194–7.

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