ODAC asks FDA to retain Tecentriq, Keytruda accelerated approvals for bladder cancer
Next up: panel weighs Keytruda, Opdivo for second-line liver cancer
Committee swayed by clinical experience and lack of alternatives over failure of postmarket trials to verify benefit.
FDA’s ODAC on Wednesday told FDA to look past postmarket trials that failed to verify clinical benefit and maintain two accelerated approvals for immunotherapies as frontline options for urothelial cancer, citing clinical experience and a lack of alternatives.
The Oncologic Drugs Advisory Committee voted 5 to 3 to retain accelerated approval for