FDA Approves New Treatment for Common Form of Skin Cancer

Although domestically advanced basal skin cancer fails to expand tends other areas of one’s whole body, it does not be set along with going under the knife or radiation hazard procedures.

Odomzo (sonidegib) was cleared to treat locally advanced basal cell carcinoma in patients who can not undergo surgery or radiation therapy, or whose skin cancer has returned after surgery or radiation therapy. Basal cell carcinomas account for 80 percent of non-melanoma skin cancers.

Odomzo is an oral, selective smoothened (SMO) inhibitor that regulates the hedgehog (Hh) signaling pathway, which is critical in stem cell maintenance and tissue fix. “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”.

Labeling for sonidegib will include a boxed warning about a potential for fetal death or severe birth defects in developing fetuses of women treated with sonidegib during pregnancy.

The FDA based its decision in part on the results of an global multicenter, double-blind, non-comparative randomized trial of 230 patients with metastatic basal cell carcinoma or locally advanced basal cell carcinoma not amenable to local therapies. The primary endpoint was the durable objective response rate (ORR) among patients with laBCC receiving Odomzo 800mg daily.

Based on these data, the recommended dose and schedule for sonidegib is 200 mg once daily on an empty stomach, at least 1 hour prior to or 2 hours following a meal. According to the FDA, half of the responses have persisted for 6 months or longer. The most common side effects included muscle spasms, hair loss, distorted taste, fatigue, nausea, muscle and bone pain, diarrhea and weight loss. Some people also reported muscle pain, abdominal pain, headache, vomiting and itching. “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 Bruno Strigini, president, Novartis Oncology.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.