Note: BLA voluntarily withdrawn, announced 2026-09-25: FDA indicated the IDeate-Lung01 Phase 2 data do not satisfy requirements to support accelerated approval for the proposed indication. Development continues in Phase 3 IDeate-Lung02. Source: https://www.merck.com/news/ifinatamab-deruxtecan-biologics-license-application-for-certain-patients-with-previously-treated-extensive-stage-small-cell-lung-cancer-voluntarily-withdrawn/
Drug Information
- Drug Name
- Ifinatamab deruxtecan (I-DXd) (CT.gov)
- Application Type
- BLA
- FDA Designations
- Priority ReviewBreakthroughOrphan Drug
- Indication
- Extensive-stage small cell lung cancer (ES-SCLC) after platinum chemo
- Approved As
- Ifinatamab deruxtecan (I-DXd)
Filing Details
- Company
- Merck & Co., Inc. →
- Stock Ticker
- MRK
- SEC CIK
- 0000310158
- Source
- Company IR →
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
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Data sourced from SEC EDGAR filings. Last updated: 2026-04-20. Report an issue