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FDA Approves New Skin Cancer Drug

by Erinn Hutkin
Wed, Aug 19th 2015 11:00 am
San Diego Union Tribune  [ View Original Article ]

Late last month, a new drug to treat the most prevalent form of skin cancer was approved by the Food and Drug Administration.

WebMD said the drug Odomzo received approval for treating locally advanced basal cell carcinoma in patients who are not candidates for surgery or radiation, or for patients whose skin cancer returns following surgery or radiation.

According to WebMD, basal cell carcinoma makes up roughly 80 percent of non-melanoma skin cancers.

Odomzo is taken as a daily pill that suppresses a molecular pathway that's active in basal cell cancers.

The drug was approved based on a clinical trial of 66 patients who took 200 milligrams of the drug daily and 128 patients who took 800 mg daily.

During the study, tumors shrank or disappeared in 58 percent of those in the 200 mg group. The shrinking results lasted two to 19 months, and six months or more in about 50 percent of cases.

Among patients in the 800 mg group, the response rates were similar, but more side effects were reported, the FDA said.

When taken at the lower dose, common side effects of the drug included muscle spasms, hair loss, problems with taste, fatigue, nausea, musculoskeletal pain, diarrhea, and decreased weight and appetite. Some patients reported muscle or abdominal pain, headaches, vomiting or itching.


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