Is Loncastuximab tesirine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Loncastuximab tesirine, including Zynlonta (10 mg, Powder for concentrate for solution for infusion, SAR 75843.30).

Is Loncastuximab tesirine approved by the US FDA?

Drugs@FDA lists 1 application product line for Loncastuximab tesirine, including ZYNLONTA (Prescription).

Is Loncastuximab tesirine authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Loncastuximab tesirine: Zynlonta.

Are there safety signals or safety updates for Loncastuximab tesirine?

US FDA: 1 entry (latest 2026-02-20).

Active substance

Loncastuximab tesirine

SFDA 1
US FDA 1
EMA 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Zynlonta	10 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 75843.30	Biological · Prescription	SWEDISH ORPHAN BIOVITRUM INTERNATIONAL AB	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
ZYNLONTA	10MG	injectable · injection	ADC Therapeutics SA	Prescription	23 Apr 2021

EMA European Union — centrally authorised medicines

Zynlonta Swedish Orphan Biovitrum AB · Authorised · authorised 20 Dec 2022 · ATC L01FX22

Therapeutic indication (EMA)

Zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy.

Safety signals and safety-related labeling changes

US FDA 20 Feb 2026 ZYNLONTA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for loncastuximab tesirine →

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.