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FDA Approves New Drug For Advanced Skin Cancer After Radiation, Surgery Options

| Jul 25, 2015 09:40 AM EDT

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The United States Food and Drug Administration (FDA) has approved an innovative drug as a treatment for the most common type of cancer, which forms in the top layer of humans' skin. It received the green light for patients suffering from an advanced stage of the disease that has not spread beyond the body's covering, yet radiation therapy or surgery did not cure the medical condition.   

The pill's commercial name is Odomzo, and is chemically referred to as sonidegib. It was created by Novartis AG, a Swiss drug producer with U.S. headquarters in New Jersey, to treat basal cell carcinoma.

This variety comprises around 80 percent of non-melanoma cancers of the skin, according to MedicalXpress. Basal cell skin cancers typically result from regular sun exposure and other sources of ultraviolet (UV) radiation.

Odomzo works by slowing down or halting the growth of cancerous tumors. The daily tablet does that by suppressing a critical molecular pathway.

The new medication includes various side effects. They include hair loss, muscle spasms, nausea, and diarrhea, according to ABC News.   

The FDA decided to approve the drug after conducting a clinical trial. In the study 66 patients consumed 200 milligrams (mg) of Odomzo daily, and 128 volunteers took 800 mg daily.

In the 200-mg group cancerous tumors shrank or vanished in 58 percent of the patients. The results lasted for at least 6 months in around half the cases.

Meanwhile, the 800-mg group had similar success rates. However, the frequency of side effects was also higher.  

Novartis will launch the new cancer pharmaceutical soon. However, it has not disclosed the price tag.

Skin cancer is the most common type of cancer. Each year in the U.S. physicians diagnose around 3.5 million cases of squamous cell and basal skin cancer.

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