Health regulators have approved a new treatment for the most common form of skin cancer. The U.S. Food and Drug Administration (FDA) on Thursday green-lighted a drug developed by Novartis for advanced basal cell carcinoma, a type of skin cancer that can be easily treated if it is caught early enough.
Skin cancer is the most prevalent form of cancer and about 80 percent of non-melanoma skin cancers come in the form of basal cell carcinoma. The condition starts in the epidermis, or the topmost layer of the skin, and progresses in areas that are often exposed to the sun and ultraviolet radiation. It often occurs on the neck and the head with the nose being the most commonly affected site.
The National Cancer Institute says that the cases of new non-melanoma skin cancer appear to increase annually.
Odomzo (sonidegib) has been approved for use by patients whose cancer has not yet spread to other parts of the body but recurred after radiation therapy or surgery.
The pill is taken once daily and works by inhibiting the molecular pathway that is active in basal cancer cells, the Hedgehog pathway. The drug is able to stop or reduce the growth of cancerous lesions by suppressing this pathway.
Richard Pazdur, from FDA's Center for Drug Evaluation and Research said the improved understanding of molecular pathways associated with cancer has paved way to the approval of many cancer drugs for diseases that are difficult to treat and which previously only have a few treatment options that existed.
"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 three years," Pazdur said.
Odomzo comes with a boxed warning informing health professionals that the drug may cause severe birth defects or even death in developing fetus when it is given to pregnant women necessitating the verification of a patient's pregnancy status prior to starting the treatment.
"The FDA approval of Odomzo offers a new and non-invasive treatment option for a potentially devastating disease that is hard to treat and can be disfiguring," said Novartis Oncology President Bruno Strigini. "Odomzo is an important addition to our growing portfolio of targeted treatments for advanced skin cancers and underscores our commitment to developing and bringing to market new options for patients."
Other known side effects of the drug include nausea, muscle spasms, hair loss, diarrhea, reduced weight, abdominal pain, decreased appetite, vomiting and headache.
Photo: Vinod Velayudhan | Flickr
