USA – FDA guidance focuses on Real-Time Oncology Review program

How does a cancer drug cross the FDA finish line 3-5 months before its PDUFA date? That’s where the Real-Time Oncology Review comes in.

For the last five years, FDA’s Oncology Center of Excellence under Rick Pazdur has been quietly tapped into RTOR to allow sponsors to provide even earlier, segmented submissions of critical efficacy and safety data, thereby enabling these faster evaluations of applications.

On Friday, OCE provided its first draft guidance on the RTOR program, explaining how sponsors can apply, what to submit if accepted, and how RTOR is different from rolling reviews, in that rolling reviews require complete sections (e.g., the complete clinical module) to be submitted prior to a complete application submission…