RHHBY
Tecentriq (atezolizumab) + chemotherapy
FDA PDUFA Target Action Date · Genentech (Roche)
Friday, October 9, 2026
93 days away
Drug Information
- Application Type
- sBLA
- FDA Designations
- Priority Review
- Indication
- Adjuvant stage III dMMR/MSI-H colon cancer
Filing Details
- Company
- Genentech (Roche)
- Stock Ticker
- RHHBY
- SEC CIK
- Source
- Company PR →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
Track All FDA Decisions
View all upcoming PDUFA dates and AdCom meetings on our FDA Calendar.
View FDA Calendar →Data sourced from SEC EDGAR filings. Last updated: 2026-06-29. Report an issue