FDA Approves Genentech Cancer Drug

The US Food and Drug Administration (FDA) announced today that it had approved Erivedge (vismodegib), a cancer drug manufactured by Genentech, Inc. The oral, once-daily medication is intended to treat adults with advanced basal cell carcinoma. According to a Genentech press release, vismodegib is the first FDA-approved drug for the advanced forms of the most common type of skin cancer. Genentech said vismodegib will be available in specialty pharmacies within 1 to 2 weeks. A single-arm, parallel cohort study of 96 patients who received 150 mg of vismodegib daily found that 30.3% of patients with metastatic basal cell carcinoma (mBCC) had an objective response compared with 42.9% of patients with locally advanced basal cell carcinoma (laBCC). The median response was 7.6 months in both groups. The most common adverse reactions (occurring in >10% of patients who received vismodegib as monotherapy for laBCC or mBCC) were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia. Read the FDA's press release at https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm289571.htm?source=govdelivery Read Genentech's press release at https://www.gene.com/gene/news/press-releases/display.do?method=detail&id=13827 -Tim Casey