Skin cancer is the most common type of cancer. It is estimated that about 80% of non-melanoma skin cancers are of the basal cell carcinoma subtype. The FDA has recently approved Novartis Odomzo® (sonidegib) for the treatment of locally advanced basal cell carcinoma for adult patients who are not candidates for surgery or radiation therapy or whose disease has recurred.
The National Cancer Institute has released alarming statistics for non-melanoma skin cancer, where the number of new cases appears to be increasing by 10% every year due to the aging of the population and to an increased exposure to UV radiation. Basal cell carcinoma (BCC) belongs to the non-melanoma type of skin cancer. It develops from the skin's basal cells in the epidermis, the outermost layer of the skin. BCC occurs most frequently on the head and neck, with the nose being the most common site. BCC that has spread from its primary site is called locally advanced (laBCC), it represent about 1-10% of all cases and can be highly disfiguring. An estimated 3% of BCC patients comes back with recurring disease after five years from initial treatment and for these patients further treatment options are limited.
The FDA approval of the hedgehog inhibitor sonidegib (Odomzo) for the treatment of laBCC is based on the results from the Phase II BOLT multi-center, double blind clinical trial in which 194 patients with laBCC were randomly assigned to receive Odomzo 200 mg or 800 mg daily.
The study’s results showed that 58 percent of patients treated with 200 mg sonidegib had their tumors shrink or disappear and strikingly this effect lasted, in same cases for as long as 18 months. Response rates were similar in patients who received Odomzo 800 mg daily, however side effects were more common at this dose.
Odomzo is a targeted inhibitor of smoothened (SMO), a key regulator of the hedgehog (Hh) signaling pathway, which controls stem cell maintenance and tissue repair, and when deregulated promotes abnormal cell growth leading to cancer. This is the second Hh signaling inhibitor approved by the FDA for the treatment of basal cell carcinoma after the Genentech/Roche Erivedge® (vismodegib), which passed the FDA mark in 2012.
Followig the FDA approval, also the European Committee for Medicinal Products for Human Use issued a positive opinion for sonidegib’s use in the treatment of laBCC. Odomzo was approved in Switzerland for the treatment of advanced laBCC at the end of June this year. Additional regulatory submissions are currently being reviewed by health authorities worldwide.
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