March 25,Regeneron(Regeneron) announced that it has received a communication from the U.S. FDA regardingIts CD3/CD20 bispecific antibodyodronextamabTreatment of Relapsed/Refractory (R/R) Follicular Lymphoma (FL) and R/R Diffuse Large B-CellComplete Response Letter (CRL) issued for the BLA application of lymphoma (DLBCL).Regeneron stated that the sole reason was related to confirming the clinical enrollment status, and was unrelated to efficacy or safety, clinical design, labeling, or production issues.
Due to this itemBLAIt is based on the positive results of the Phase I ELM-1 study and Phase II ELM-2 study. Therefore, according to regulations, Regeneron should complete the confirmatory trial before drug approval.Patient enrollment for OLYMPIA.According to Regeneron,As the largest lymphoma clinical programOLYMPIAAs part of this, the company has been actively recruiting patients for multiple Phase III trials of odronextamab.The OLYMPIA project aims to change the treatment paradigm for several subtypes of B-cell non-Hodgkin lymphoma (including early treatment lines). The FDA has also approved the project, while requiring that the trial include dose-finding and confirmatory trial components.Patient enrollment for the dose-finding portion has begun, but the CRL requiresConfirmatory TrialThe relevant sections should also be underway, and the timeline for trial completion must be agreed upon before resubmitting the application.Regeneron stated that the company is committed to working closely with the FDA and researchers to bring odronextamab to R/R FL and R/R DLBCL patients as soon as possible.The company plans to share more information later this year.Latest Information on Registration and Regulatory Timelines.The European Medicines Agency (EMA) is still conducting regulatory reviews of odronextamab for the treatment of R/R DLBCL and R/R FL. In the EU, odronextamab has been granted orphan drug designation for the treatment of DLBCL and FL.。Copyright © 2024 PHARMCUBE. All Rights Reserved.Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article in a prominent position;For reprint, please leave a message or send a message to the WeChat Official Account backend, and indicate the name and ID of the official account.Disclaimer: The information in this WeChat article is for general reference only and should not be directly used as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.
