Yes, because the RTOR program exists, and the reasons why it exists.
Can you think of:
(1) a new biologic that recently completed its Phase III clinical trial, (2) has its top line data from that Phase III trial, (3) the new biologic is intended to be a new oncology or cancer treatment, (4) the Phase III trial results showed a significant improvement over available treatment therapy?
According to the FDA, they created this program to:
ensure that safe and effective treatments are available to patients as early as possible, while maintaining and improving review quality and balancing the review team’s workload through data and analysis standardization, and early iterative engagement with the applicant.
Also, because 2 of the required criteria required for a new drug or biological to use the FDA’s RTOR program are:
(1) Drugs likely to demonstrate substantial improvements over available therapy, which may include drugs previously granted breakthrough therapy designation for the same or other indications. (2) Endpoints that can be easily interpreted (e.g. overall survival, progression free survival, etc.).
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