Drugs / Ifinatamab Deruxtecan (I-DXd)
Ifinatamab Deruxtecan (I-DXd)
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | small cell lung carcinoma | 2026-04-13 | “Biologics License Application (BLA) for ifinatamab deruxtecan (I-DXd) has been accepted and granted Priority Review by the U.S. Food and Drug Administration (FDA)” merck.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT05280470 | Mar 2022 → Mar 2025 overdue | small cell lung carcinoma | Daiichi Sankyo | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-04-13 | Merck Sharp & Dohme LLC | Regulatory Ifinatamab Deruxtecan Granted Priority Review in the U.S. for Adult Patients with Previously Treated Extensive-Stage Small Cell Lung Cancer who Experienced Disease Progression on or After Platinum-Based Chemotherapy merck.com ↗
Daiichi Sankyo (TSE: 4568) and Merck’s (NYSE: MRK), known as MSD outside of the United States and Canada, Biologics License Application (BLA) for ifinatamab deruxtecan (I-DXd) has been accepted and granted Priority Review by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. |
| 2025-09-07 | Merck Sharp & Dohme LLC | Results Ifinatamab Deruxtecan Demonstrated Clinically Meaningful Response Rates in Patients with Extensive-Stage Small Cell Lung Cancer in IDeate-Lung01 Phase 2 Trial merck.com ↗
Results from the IDeate-Lung01 Phase 2 trial showed that ifinatamab deruxtecan (I-DXd) demonstrated clinically meaningful response rates in patients with previously treated extensive-stage small cell lung cancer (ES-SCLC). |
| 2025-08-18 | Merck Sharp & Dohme LLC | Regulatory Ifinatamab Deruxtecan Granted Breakthrough Therapy Designation by U.S. FDA for Patients with Pretreated Extensive-Stage Small Cell Lung Cancer merck.com ↗
Ifinatamab deruxtecan (I-DXd) has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. |
| 2024-09-07 | Merck Sharp & Dohme LLC | Results Ifinatamab Deruxtecan Continues to Demonstrate Promising Objective Response Rates in Patients with Extensive-Stage Small Cell Lung Cancer in IDeate-Lung01 Phase 2 Trial merck.com ↗
Results from an interim analysis of the dose-optimization part of the ongoing IDeate-Lung01 phase 2 trial showed ifinatamab deruxtecan (I-DXd) continues to demonstrate promising objective response rates in patients with pretreated extensive-stage small cell lung cancer (ES-SCLC). |
All press releases naming this drug 4 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ifinatamab Deruxtecan (I-DXd) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05280470 ↗ |
| Modality | Other / unclassified | “a B7 homolog 3-directed antibody-drug conjugate” PMID 41086386 ↗ Oct 2025 |
| Route | Intravenous | “I-DXd will be administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle (every Q3W).” NCT05280470 ↗ |