ODAC (Oncologic Drugs Advisory Committee)
A panel of outside experts the FDA convenes to debate contentious cancer drug applications in public and vote on whether the evidence is adequate. The FDA usually, but not always, follows the vote.
ODAC meetings dissect trial design, crossover, subgroup results, dosing and the applicability of foreign data; landmark sessions include the 2021 review of 'dangling' accelerated approvals, the 2022 discussion of China-only trials, the 2023-24 debates on dose optimisation and on PD-1 inhibitors in PD-L1-low gastric and oesophageal cancer, and the 2025 votes on camizestrant (SERENA-6) and belantamab dosing. Briefing documents published before meetings are among the most candid public analyses of oncology trials. Similar committees exist at the EMA (CHMP with its scientific advisory groups).