FDA approve new daily pill for common skin cancer

FDA approve new daily pill for common skin cancer

 The US regulators have approved a new drug for the treatment of locally advanced basal cell carcinoma  a form of skin cancer.

Taken in the form of a daily pill, Odomzo (generic name sonidegib) is marketed by Novartis AG - a Swiss pharma giant with US headquarters in East Hanover, NJ.

The US Food and Drug Administration (FDA) say a trial showed the drug shrank or wiped out tumors in 58% of patients treated.

The regulators note that the drug is intended for patients with locally advanced basal cell carcinomas who are not candidates for surgery or radiotherapy, or whose tumors have recurred following such treatment.

Skin cancer is the most common cancer in the US. Most skin cancers are nonmelanoma cancers like basal cell carcinoma (BCC), which accounts for around 80% of nonmelanoma cancers.

Nonmelanoma skin cancers usually respond to treatment and rarely spread to other parts of the body.

The National Cancer Institute suggest the number of Americans diagnosed with nonmelanoma skin cancers is increasing every year.

BCCs arise in basal cells in the top layer of skin - the epidermis - usually in places that receive regular sun exposure or other forms of ultraviolet (UV) radiation. They occur most frequently on the head and neck, with the nose being the most common site.

Drug suppresses the Hedgehog molecular pathway

Locally advanced basal cell carcinomas (laBCCs) are basal cell cancers that have spread to nearby tissue (but not to the rest of the body) and do not respond to locally targeted treatment - that is, surgery and radiotherapy. They can be highly disfiguring.

Odomzo is a pill taken once a day. It works by suppressing the Hedgehog molecular pathway, which is active in basal cell cancers.

Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the Center for Drug Evaluation and Research at the FDA, says:

"Thanks to a better understanding of the Hedgehog pathway, the FDA has now approved two drugs for the treatment of basal cell carcinoma just in the last 3 years."


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