Karen Midthun, MD
In the pivotal trial, T-VEC significantly extended durable response rates (DRR) compared with GM-CSF. DRR was the primary endpoint, with overall survival (OS) as a secondary endpoint. In the final OS analysis, a 4.4-month extension with T-VEC was observed; however, this was not deemed to be statistically significant (P = .051).
Based on the OPTiM data, members of the FDA’s ODAC and CTGTAC panels voted 22-1 to recommend approval of T-VEC following a joint committee meeting in late April. Click here to read the full article at OncLive.com