P&U CAMPTOSAR PHASE III/IV TRIAL SHOULD ADD SECOND-LINE USE DATA, FDA CMTE. SAYS; ACCELERATED APPROVAL FOR REFRACTORY COLORECTAL CANCER URGED
Executive Summary
Pharmacia & Upjohn should randomize patients to receive Camptosar following failure of 5-fluorouracil/leucovorin therapy in its ongoing Phase III/IV trial to confirm clinical benefit in refractory colorectal cancer patients, FDA's Oncologic Drugs Advisory Committee recommended at its June 13 meeting.