Overview
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Indication
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Associated Conditions
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Research Report
Comprehensive Report on Tarlatamab (Imdelltra)
I. Introduction to Tarlatamab (Imdelltra)
A. Overview and Development
Tarlatamab, also known by its development code AMG-757 and marketed under the brand name Imdelltra, is an innovative antineoplastic agent engineered and developed by Amgen.[1] It represents a significant advancement in immunotherapy, specifically as a first-in-class agent targeting Delta-like ligand 3 (DLL3).[1] The development of Tarlatamab has been driven by the critical unmet medical need in treating aggressive hematological malignancies and solid tumors, particularly extensive-stage small cell lung cancer (ES-SCLC), a disease notorious for its rapid progression and limited effective treatment options following initial platinum-based chemotherapy.[5]
The designation of Tarlatamab as a "first-in-class" bispecific T-cell engager (BiTE) targeting DLL3 signifies a novel therapeutic strategy for SCLC.[1] This unique position underscores its potential to significantly alter the treatment landscape for this challenging cancer, provided its efficacy and safety are robustly confirmed in broader patient populations and potentially in earlier lines of therapy. SCLC has long been characterized by poor prognoses and a lack of durable responses to conventional treatments beyond the first line. The introduction of a therapy with a distinct mechanism of action, such as Tarlatamab, offers new hope for patients who have exhausted standard therapeutic avenues.
B. Chemical and Physical Properties
Tarlatamab is a biologic medication with the following identifiers and characteristics:
- DrugBank ID: DB17256 [1]
- CAS Number: 2307488-83-9 [1]
- Type: Biotech; specifically, it is a human monoclonal antibody engineered as a Bi-specific T-cell Engager (BiTE).[1]
- Molecular Formula: C4664H7139N1259O1454S34 [1]
- Molar Mass: Approximately 105202.82 g·mol$^{-1}$ [1]
- Source: Human [1]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/07/11 | Not Applicable | Not yet recruiting | Grupo Espanol de Tumores Neuroendocrinos | ||
2025/06/25 | Phase 1 | Not yet recruiting | |||
2025/06/11 | Phase 2 | Recruiting | |||
2025/06/05 | Phase 3 | Not yet recruiting | |||
2025/04/22 | Phase 3 | Not yet recruiting | Intergroupe Francophone de Cancerologie Thoracique | ||
2025/03/27 | Phase 1 | Recruiting | |||
2025/03/25 | Phase 2 | Not yet recruiting | Inkeun Park | ||
2025/02/10 | Phase 2 | Not yet recruiting | |||
2025/02/07 | Phase 1 | Not yet recruiting | |||
2025/01/15 | Phase 2 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
No FDA approvals found for this drug. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
♐ IMDELLTRA POWDER FOR CONCENTRATE AND SOLUTION FOR SOLUTION FOR INFUSION 10MG/VIAL | N/A | N/A | N/A | 1/17/2025 | |
♐ IMDELLTRA POWDER FOR CONCENTRATE AND SOLUTION FOR SOLUTION FOR INFUSION 1MG/VIAL | N/A | N/A | N/A | 1/17/2025 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
IMDELLTRA tarlatamab 1 mg powder for injection vial with intravenous (IV) solution stabiliser vial composite pack | 453165 | Medicine | A | 6/26/2025 | |
IMDELLTRA tarlatamab 10 mg powder for injection vial with intravenous (IV) solution stabiliser vial composite pack | 453166 | Medicine | A | 6/26/2025 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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