Chart: Sponsors Go 2 For 4 At ODAC With Pazdur On The Mound
Executive Summary
An extended baseball analogy by some committee members is as close as sponsors came to hitting anything out of the park during the Sept. 1-2 meeting of FDA's Oncologic Drugs Advisory Committee. ODAC agreed with FDA that randomized controlled trials - which none of the four drugs reviewed had - were needed for approval, but members were less adamant about that principle when applying it might mean leaving patients on base.