On November 16, 2023, the Oncology Drug Advisory Committee will receive updates on the accelerated approval program in oncology and two new drug applications (NDAs) approved under 21 CFR 314.500 (subpart H, accelerated approval regulations) that have not met their agreed-upon milestones for completion of confirmatory trial(s). These updates will provide information on the status of all accelerated approvals granted in oncology, including products with delayed confirmatory trials, and the status of confirmatory trials for the specific NDAs to be discussed, including any ongoing and planned trials.