Is Tarlatamab approved by the US FDA?

Drugs@FDA lists 1 application product line for Tarlatamab, including IMDELLTRA (Prescription).

Is Tarlatamab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Tarlatamab: Imdylltra.

Are there safety signals or safety updates for Tarlatamab?

US FDA: 1 entry (latest 2026-09-11).

Active substance

Tarlatamab

US FDA 1
EMA 1
Health Canada 2
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
IMDELLTRA	1MG; 10MG	injectable · injection	AMGEN INC	Prescription	16 May 2024

EMA European Union — centrally authorised medicines

Imdylltra Amgen Europe B.V. · Authorised · authorised 29 May 2026 · ATC L01FX33

Therapeutic indication (EMA)

Imdylltra is indicated as monotherapy for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), who require systemic therapy following disease progression on or after first-line treatment with platinum-based chemotherapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
IMDELLTRA	02551551	1 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	AMGEN CANADA INC
IMDELLTRA	02551578	10 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	AMGEN CANADA INC

Safety signals and safety-related labeling changes

US FDA 11 Sep 2026 IMDELLTRA — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for tarlatamab →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.