FDA Approval Summary: Epcoritamab with Lenalidomide and Rituximab for Relapsed or Refractory Follicular Lymphoma. (PubMed, Clin Cancer Res) - Oct 2, 2026 - "ORR per IRC was significantly higher in the epcoritamab plus R2 arm, based on prespecified analysis of the first 232 patients assessed (96% vs. 81% with R2;p<0.0001). This article summarizes key aspects of the regulatory review, including endpoint selection, randomized dose optimization, and a potential single-trial approach to support both accelerated and subsequent traditional approval."
FDA event • Journal • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology
|
|
Bindu Kanapuru; Hui Wei; Jiang Liu; Keng Hee Peh; Natasha Kormanik; Nicole J Gormley; Ólanrewaju O Okusanya; R Angelo de Claro; Rachel Ershler; Somak Chatterjee; Theresa Carioti; Xiling Jiang; Xueping Zhou; Yuan Li Shen; Yvette L Kasamon
|