Faster-than-expected FDA approval of Roche's vismodegib

There was good news for Swiss drug major Roche's (ROG: SIX) subsidiary Genentech yesterday, when it received approval from the US Food and Drug Administration for Erivedge (vismodegib) to treat adult patients with basal cell carcinoma, the most common type of skin cancer. Roche’s shares moved 0.9% higher to 156.70 Swiss francs in early morning trading today.

The drug is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients whose cancer has spread to other parts of the body (metastatic).

Erivedge, reviewed under the agency's priority review program, is the first FDA-approved drug for metastatic basal cell carcinoma (The Pharma Letter November 10, 2011). Erivedge was reviewed under the agency's priority review program that provides for an expedited six-month review of drugs that may offer major advances in treatment. The drug is being approved ahead of the March 8, 2012, prescription user fee goal date (PUFDA).