FDA Approves Skin Cancer Drug for 'Major Advances in Treatment'

The U.S. Food and Drug Administration on Monday gave a green light to a basal cell skin cancer drug made by Roche Holding AG and Curis Inc. The drug will be marketed by Roche's San Francisco-based Genetech arm under the brand name Erivedge.

Erivedge is the first FDA-sanctioned drug to treat metastatic basal cell carcinoma, the most common type of skin cancer. The FDA said the drug should be for use with basal cell cancer patients that are not candidates for surgery or radiation and for other patients whose cancer has infiltrated other parts of their bodies.

Erivedge was placed under the FDA's priority review system, which allows for a six-month expedited review of drugs that provide major advances in treatment. Erivedge, taken once a day by the patient, inhibits the so-called Hedgehog pathway, the FDA said.

Our understanding of molecular pathways involved in cancer, such as the Hedgehog pathway, has enabled the development of targeted drugs for specific diseases, Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a statement.

This approach is becoming more common and will potentially allow cancer drugs to be developed more quickly. This is important for patients who will have access to more effective therapies with potentially fewer side effects.

The FDA reviewed Erivedge in a clinical study involving 96 patients with locally advanced or metastatic basal cell carcinoma. In the study, 30 percent of metastatic patients experienced a partial shrinkage of tumors. Forty-three percent of locally advanced patients had a partial or even complete response.

The common side effects exhibited by patients included muscle spasms, hair loss, weight loss, nausea, diarrhea, fatigue, distorted sense of taste, decreased appetite, constipation, vomiting and loss of taste in the tongue. The FDA will place a warning on the drug's box of potential risk of death and severe birth defects.