Indication · Base-Rate Reference
Oncology FDA Approval Rates
Historical first-cycle FDA approval rates for Oncology assets across 8 regulatory pathways — NDA Standard, NDA Priority, BLA, sBLA, Class 2 Resubmission, Accelerated Approval, Breakthrough Therapy, Fast Track.
What's specific about Oncology at FDA?
The highest-volume therapeutic area at FDA. Approvals increasingly tied to biomarker-defined populations. Accelerated Approval is common; CRLs often driven by CMC or confirmatory trial design.
Oncology base rates by pathway
| Pathway | First-cycle approval | Sample size | Typical clock | AdCom | Notes |
|---|---|---|---|---|---|
| sBLA | 88% | n~300 | priority 6 months | rarely | Label expansions for approved checkpoint inhibitors, ADCs, and targeted therapies; first-cycle approval common. |
| Breakthrough Therapy | 88% | n~180 | priority 6 months | rarely | Breakthrough designation correlates strongly with first-cycle approval; high single-arm study acceptance. |
| Accelerated Approval | 85% | n~150 | priority 6 months | sometimes | Most accelerated approvals are oncology; increased FDA scrutiny on confirmatory trial timelines post-FDORA. |
| NDA Priority | 82% | n~200 | priority 6 months | sometimes | Priority review reflects unmet need; first-cycle approval rates notably higher than standard review. |
| BLA | 78% | n~100 | priority 6 months / standard 10 months | sometimes | CAR-T, bispecifics, and checkpoint inhibitors; CMC and comparability issues common CRL drivers. |
| Class 2 Resubmission | 75% | n~60 | 6 months from resubmission | sometimes | Class 2 resubmissions address major issues; second-cycle approvals common when CMC or data issues resolved. |
| Fast Track | 72% | n~200 | varies; often priority 6 months | sometimes | Fast Track enables rolling review; approval rates higher than non-designated peers but below Breakthrough. |
| NDA Standard | 70% | n~150 | standard 10 months | sometimes | Approvals increasingly tied to biomarker-defined populations; CRLs often driven by manufacturing/CMC or confirmatory trial design. |
Base rates drawn from published FDA approval analyses covering roughly 2008-2022. Approximate — use as framing, not prediction.
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