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Cambridge MedChem Consulting

Real-Time Oncology Review Pilot Program

Clinical trials can be extremely lengthly and there have been many discussions about how to get medicines to patients more efficiently than the seemingly bureaucratic process that is currently in place.

Real-Time Oncology Review Pilot Program is a project to try and reduce the time needed to gain approval.

There are important caveats though.

Submissions to be considered for the RTOR pilot should meet the following criteria:
Drugs likely to demonstrate substantial improvements over available therapy, which may include drugs previously granted Breakthrough Therapy Designation for the same or other indications. Drugs meeting other criteria for other expedited programs (e.g. fast track, priority review) may also be considered. Straight forward study designs, as determined by the review division and the OCE. Studies conducted exclusively outside the United States and adjuvant, neoadjuvant, and prevention studies will be excluded. Endpoints that can be easily interpreted (for example, overall survival in a randomized trial). Supplements with CMC formulation changes and supplements with pharmacology/toxicology data will be excluded. Submissions with greater complexity, including those with companion diagnostics, may also be excluded for the purposes of the pilot program.

The real time review means the FDA can continuously review data as it is produced and give early feedback.

RTOR allows the FDA to review much of the data earlier, before the applicant formally submits the complete application. First, the applicant will present topline data for the FDA to determine whether RTOR would be appropriate for the supplement. If the agency determines RTOR is an appropriate review pathway, the applicant can start sending pre-submission data to the agency, under the original NDA/BLA, 2-4 weeks after all patient data has been entered and locked by the applicant in their database

This sort of process may be ideal for some indications where the trials give clear end points, survival in oncology, clearance of parasite in Malaria or other infectious diseases. Clinical trials for Psychiatric disease, marginal improvements over existing therapy or slowly progressing neurological diseases will probably not be suitable.