Has Icoritumab been officially launched? What is the latest development?

Epcoritumab (Epcoritamab), as a highly innovative bispecific T cell engager (BiTE), has attracted widespread attention in the field of lymphoma treatment. By simultaneously targeting CD20 and CD3, it prompts T cells to directly recognize and eliminate malignant B cells expressing CD20, and has precise and efficient immune clearance capabilities. The drug is initially targeted at patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL; non-Hodgkin lymphoma).

Up to now, icorituzumab has been officially approved for marketing in many countries. The U.S. Food and Drug Administration (FDA) first approved its marketing in May 2023 for the treatment of adult patients with DLBCL who are relapsed or refractory after two or more systemic treatments. Then in September 2023, the European Medicines Agency (EMA) also granted it marketing authorization, indicating that its clinical application in the EU region has officially begun. In December 2023, Health Canada also granted market access to the drug, further expanding its treatment territory in North America and Europe.

In June 2024, the FDA further expanded its indications to include patients with relapsed or refractory follicular lymphoma (FL), provided that the patients have failed at least two or more systemic treatments. Follicular lymphoma is a subtype of B-cell non-Hodgkin lymphoma that progresses slowly but is difficult to cure. This expansion enables Epcoritamab's indications to cover a wider range of B-cell malignant tumors, enhancing its clinical utility and market prospects. It is worth noting that the drug is also suitable for DLBCL transformed from indolent lymphoma and high-grade B-cell lymphoma under certain circumstances.

As for its launch progress in China, there is currently no official approval from the State Food and Drug Administration. This means thatEpcoritamab is still in the clinical research stage or registration application stage, and has not yet been officially sold in the Chinese mainland market, nor has it been included in the medical insurance system.

Reference materials:https://www.drugs.com/epcoritamab.html