BCIQ Profiles

Company Profile Report

PART 1

ODAC consequences

PART 2

ODAC Day 3

PART 2

ODAC Day 2

PART 4

ODAC Day 1

0428 ODAC day 2
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Regulation

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.

Apr 29, 2021 | 12:58 AM GMT

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

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