Lack of Assurance for Timely Completion of Confirmatory Trials
Severity: criticalThe current conduct and projected completion date of the OLYMPIA trials in follicular lymphoma do not provide sufficient assurance of timely completion of the trial(s). The sponsor must demonstrate appropriate milestones and sufficient progress in the confirmatory portion of the trial(s) prior to approval.
Recommended response: Request a meeting with the Agency to discuss trial benchmarks (e.g., enrollment goals, site activation, proportion of primary endpoint events accrued, trial completion date) and demonstrate sufficient progress in the conduct of the confirmatory portion of the confirmatory trial(s).
Comprehensive Safety Update Required
Severity: majorA comprehensive safety update is required as described at 21 CFR 601.2. This includes detailing significant changes in the safety profile, presenting new safety data from studies, retabulating adverse events, providing case report forms and narrative summaries for deaths and serious adverse events, updating exposure information, and summarizing worldwide experience.
Recommended response: Provide a detailed safety update including all specified data points: significant changes, new safety data, retabulations of adverse events, case report forms and narratives for deaths/serious AEs, updated exposure information, worldwide experience, and English translations of current approved foreign labeling.
Cited: 21 CFR 601.2
Proprietary Name Resubmission Required
Severity: minorThe proposed proprietary name was found conditionally acceptable pending approval of the application. It must be resubmitted when all other application deficiencies identified in this letter have been addressed.
Recommended response: Resubmit the proposed proprietary name after all other application deficiencies have been fully addressed.
Labeling Comments Reserved
Severity: infoComments on the proposed Prescribing Information, Carton and Container Labeling, and Medication Guide are reserved until the application is otherwise adequate. The sponsor is encouraged to review labeling resources and ensure compliance with format items.
Recommended response: Review labeling resources (Prescription Drug Labeling Resources, Pregnancy and Lactation Labeling Final Rule, SRPI checklist) and prepare to submit updated content of labeling in Structured Product Labeling (SPL) format once other deficiencies are resolved.
Cited: 21 CFR 601.14(b)
