Micrograph of a diffuse large B cell lymphoma. Credit: Nephron / commons.wikimedia.org.

The European Commission (EC) has granted conditional marketing authorisation for Sobi and ADC Therapeutics’ Zynlonta (loncastuximab tesirine) to treat relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL). 

In September this year, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use provided a positive opinion for granting the authorisation.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The latest development is based on the findings from the multinational, single-arm Phase II LOTIS-2 clinical trial of Zynlonta to treat r/r DLBCL in adults who have received two or more lines of systemic treatment previously. 

With the approval, the treatment is intended for use in all member states of the European Union, Norway, Liechtenstein and Iceland. 

Sobi Research & Development and Medical Affairs head, and chief medical officer Anders Ullman said: “We look forward to making Zynlonta available as a new treatment option to patients in the EU impacted by diffuse large B-cell lymphoma, a debilitating disease in haematology.”

The US Food and Drug Administration approved Zynlonta under an accelerated pathway in April last year for the same indication.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

A CD19-directed antibody-drug conjugate, Zynlonta attaches to a CD19-expressing cell. It is subsequently internalised by the cell, where enzymes then release a pyrrolobenzodiazepine payload. 

The payload attaches to deoxyribonucleic acid (DNA) minor groove with minimum distortion, making it less noticeable to DNA repair mechanisms. This causes the stoppage of cell cycle and death of tumour cells.

Sobi and ADC entered an exclusive licence agreement in July this year for the development and marketing of Zynlonta for haematology and other indications with unmet medical needs in Europe and other global markets.