On July 3, the Center for Drug Evaluation (CDE) accepted the clinical trial application for REGN1979 injection, a CD3/CD20 bispecific antibody submitted by Zai Lab and Regeneron.
REGN1979, developed by Regeneron, has received orphan drug designation from the FDA for the treatment of diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). On April 8, Zai Lab entered into an agreement with Regeneron to obtain the rights for the development and exclusive commercialization of REGN1979 in mainland China, Hong Kong, Taiwan, and Macau, for an upfront payment of $30 million and potential regulatory and sales milestone payments of up to $160 million.
Diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) are the two most common subtypes of B-cell non-Hodgkin lymphoma (B-NHL). DLBCL is a highly aggressive form of B-NHL, with nearly 50% of patients with advanced-stage disease experiencing disease progression (i.e., relapse or refractoriness) after first-line therapy. For patients with relapsed or refractory (R/R) DLBCL, current treatment options are limited and the prognosis is poor.
Follicular lymphoma (FL) is a slow-growing (indolent) B-cell non-Hodgkin lymphoma (B-NHL), with most cases diagnosed at an advanced stage. Although the median overall survival for patients with advanced-stage FL ranges from 8 to 15 years, current treatments are not curative, and the majority of patients experience relapse within 5 years regardless of the treatment regimen employed. In certain cases, FL transforms into diffuse large B-cell lymphoma (DLBCL), which is typically managed according to DLBCL treatment protocols.