FDA Approvals of 2012

4 of 39


Drug: Erivedge
Generic molecule: vismodegib
Company: Genentech
Approval date: Jan. 30

The scoop: Developed with partner Curis ($CRIS), Roche's ($RHHBY) Genentech won a landmark approval for the targeted cancer drug. After collecting significant efficacy data from a Phase II study on basal cell carcinoma, the company headed straight to regulators for a decision. With no other treatments available for these patients, they won the approval well ahead of the agency's decision deadline.