Definition
Real-Time Oncology Review (RTOR) is an FDA pilot program allowing early submission of efficacy data for cancer drugs before the complete application is filed. FDA begins reviewing clinical trial results in real-time, reducing overall review timelines.
How RTOR Works
Sponsors submit clinical data packages for FDA review while completing the rest of the application. FDA reviews efficacy and safety data before the official NDA/BLA filing date.
Eligibility Criteria
- Oncology indication
- Generally Breakthrough Therapy designated
- Clean clinical data package
- Sponsor agreement to participate
RTOR Process
| Stage | Activity |
|---|---|
| Pre-Submission | Sponsor submits clinical data package |
| Real-Time Review | FDA reviews efficacy/safety data |
| Application Filing | Formal NDA/BLA submitted |
| Continued Review | CMC and labeling finalized |
| Decision | Approval based on complete review |
Why BD Teams Track RTOR
For business development professionals, RTOR participation signals expedited oncology programs:
- Deal Implication: RTOR can accelerate approval by weeks, affecting launch timing and competitive positioning
- Due Diligence Focus: RTOR eligibility often indicates strong clinical data and FDA engagement
- Opportunity Signal: Oncology assets in RTOR process may be approaching critical milestones