Snapshot

The FDA Real Time Oncology Review-RTOR pathway has been developed by the US Food and Drug Administration of United States.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

At the time top-line results of a pivotal trial(s) are available and the database has been locked, an applicant may apply for review under RTOR by submitting a request via email to their assigned Regulatory Project Manager (RPM) and to the Investigational New Drug Application (IND). The applicant should include their top-line results and a written justification explaining how their application demonstrates that it is appropriate for RTOR. The applicant should also include a proposed timeline of when it will submit the various components of the RTOR application. The review division director/deputy director, with input from the review team (including reviewers, team leaders, and management from all relevant review disciplines), will decide whether the application will be selected for the RTOR program. This decision will generally be made within 20 business days of receipt of the request and communicated to the applicant via email. If the application is not accepted into the RTOR program, the applicant should follow routine application submission procedures. Once an application is selected, a teleconference with the applicant may be scheduled if necessary (generally within 20 business days). The OOD clinical division director/deputy director, the review team, and OCE staff may participate in this meeting. FDA and the applicant will discuss the plan for RTOR and reach tentative agreement on proposed submission timelines for the drug application. During the pre-NDA/BLA meeting to discuss the proposed application, FDA may share preliminary key review questions or issues and critical analyses needed. If FDA requests additional analyses, the applicant may submit them before or at the time of submission of the complete marketing application. In some cases, if FDA agrees, the applicant may submit the requested additional analyses after the marketing application is submitted. These discussions may be documented in the meeting minutes under the section, “Agreement of a Complete Application” for NDA NMEs or original 351(a) BLAs. For supplemental applications, RPMs may capture agreements discussed under “Additional Items Discussed” or under discussion of specific questions as appropriate in the official meeting minutes. The applicant submits the final component of the marketing application. Once FDA receives the final component the application is considered complete, and the review clock will start. The complete application will include any remaining components not previously submitted by the applicant. A study by de Claro et al found that the median interval between the first RTOR submission to the complete application submission is 5.7 weeks, with a range of 1.7–16.2 weeks. The same study also reports that the median time from the clinical trial data cutoff to application submission is 6.1 months with a range of 2.7–15.7 months. Additionally, the median time from application submission to approval was 3.3 months, with a range of 0.4–5.9 months