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USFDA Guidance: Real-Time Oncology Review (RTOR)

The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) released guidance earlier this week (07 November 2023) ie, "Real-Time Oncology Review (RTOR)" that provides recommendations to applicants on the process for submission of selected new drug applications (NDAs) and biologics license applications (BLAs) with oncology indications for review under Real-Time Oncology Review (RTOR).

To facilitate the FDA's evaluation of the application, the OCE developed RTOR, which allows parts of individual modules (e.g., parts of the clinical module or the safety module) to be submitted separately.

In addition to providing FDA reviewers with earlier access to data, RTOR allows them to identify data quality and potential review issues, and provide early feedback to the applicant, which can ensure an efficient and streamlined review process.

The following should be demonstrated in submissions in order to qualify for RTOR:

  • Clinical evidence from adequate and well-controlled investigation(s) indicates that the drug may demonstrate substantial improvement on a clinically relevant endpoint(s) over available therapies.

  • Easily interpreted clinical trial endpoints (e.g., overall survival, response rates), as determined by the review division and OCE.

  • No aspect of the submission is likely to require a longer review time (e.g., requirement for new REMS, advisory committee, etc.).

As part of the RTOR process, the applicant is engaged early in the process to discuss the timing of submissions for both the RTOR components and the full application. To determine eligibility for RTOR, the FDA would need the top-line efficacy and safety results from the pivotal clinical trial(s). The applicant should have already completed the database lock for the clinical trial at this point.

Click this LINK to know more about the RTOR process and what are the items the applicant should submit to their marketing application per the agreed-upon timeline.

Also, check out this guidance "COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers" released by CBER that provides recommendations to holders of approved NDAs, BLAs, and ANDAs regarding the reporting and implementation of some common changes to container closure system (CCS) components consisting of glass vials and stoppers for approved sterile drug products, including biological products, administered parenterally.


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