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Tarlatamab

Generic Name
Tarlatamab
Drug Type
Biotech
CAS Number
2307488-83-9
Unique Ingredient Identifier
74X82ST8Q1

Overview

No overview information available.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Research Report

Published: May 14, 2025

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: C4664​H7139​N1259​O1454​S34​ [1]
  • Molar Mass: Approximately 105202.82 g·mol$^{-1}$ [1]
  • Source: Human [1]

Continue reading the full research report

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.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
IMDELLTRA
Amgen Canada Inc
02551551
Powder For Solution - Intravenous
1 MG / VIAL
11/28/2024
IMDELLTRA
Amgen Canada Inc
02551578
Powder For Solution - Intravenous
10 MG / VIAL
11/28/2024

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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