AbbVie (ABBV.US) filed a new indication for the approval of its monoclonal antibody drug, Imbruvica, in China.

On September 23, the website of the Center for Drug Evaluation (CDE) showed that AbbVie's epcoritamab injection was being applied for a new indication in China. According to the progress of priority review, the indication for this application is for the treatment of relapsed or refractory follicular lymphoma (FL) in adult patients with the combination of rituximab and lenalidomide. Epcoritamab is an IgG1 bispecific antibody developed by Genmab using its proprietary DuoBody technology, which can simultaneously target CD3 on T cells and CD20 on B cells, inducing T cell killing of CD20+ cells. On August 7, a Phase III study (EPCORE FL-1 study) evaluating the efficacy and safety of epcoritamab in combination with rituximab and lenalidomide compared to rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (R/R FL) showed positive results. The interim analysis showed that the study had met its primary endpoints of ORR and PFS. Epcoritamab, in combination with rituximab and lenalidomide, achieved an ORR of 95.7% (p<0.0001) in the United Therapeutics Corporation group, with a PFS hazard ratio (HR) of 0.21 (p<0.0001), reducing the risk of disease progression or death by 79%. The FDA has accepted a supplemental Biologics License Application (sBLA) for epcoritamab for this indication and granted it priority review status, with a PDUFA date of November 30, 2025.