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Prof. Dr. Mustafa Özdoğan · Medical Oncologist

A new drug and new hope for skin cancer, the most common cancer: sonidegib (Odomzo)

A new drug and new hope for skin cancer, the most common cancer: sonidegib (Odomzo)

Skin cancers are the most common cancers, accounting for approximately half of all cases. Most have low metastatic potential and are often detected early. According to their cells of origin, they are generally divided into melanoma, arising from pigment-producing melanocytes, and nonmelanoma; approximately %98 are nonmelanoma. Nonmelanoma skin cancers have 2 main common types: basal cell and squamous cell cancer.

Basal cell cancers develop through abnormal, uncontrolled proliferation of basal cells in the outer skin layer and account for approximately %80 of nonmelanoma skin cancers. Excessive exposure to ultraviolet sunlight is the most important cause. Early basal cell skin cancers can be cured through local treatment such as surgery or radiotherapy, whereas locally advanced or metastatic cancers require effective systemic treatment. A recent important development for locally advanced basal cell skin cancer is Sonidegib (Odomzo) , a new effective drug approved by the FDA. Although approval is a difficult, lengthy process, it offers important assurance about benefit–risk balance. This drug is intended for locally advanced basal cell skin cancer recurring after surgery or radiotherapy or unsuitable for those treatments.

Sonidegib inhibits an intracellular mechanism active in basal cell cancers, stopping or reducing tumor growth. A clinical study demonstrated its effectiveness: 194 patients with locally advanced basal cell cancer received sonidegib, and tumor shrinkage or disappearance was evaluated. More than half showed significant shrinkage or disappearance; in half of these patients, the effect lasted at least 6 months, with an overall duration of approximately 2-19 months. The ideal daily dose was set at 200 mg.

In conclusion, Although basal cell cancer is the most common skin cancer, we have insufficient weapons against it. Local treatments give positive early-stage results, but advanced treatment options are very limited. Approval of sonidegib expands those options, offering hope both to these patients and other cancer patients closely following developments.

Sources

1. Michael R Migden et al.
Treatment with two different doses of sonidegib in patients with locally advanced or metastatic basal cell carcinoma (BOLT): a multicentre, randomised, double-blind phase 2 trial.
Lancet Oncol. 2015;16:716-728.
https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2815%2970100-2/abstract

2. U.S. Food and Drug Administration, Press Announcements.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm455862.htm
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