AbbVie granted breakthrough therapy designation for epcoritamab-bysp

AbbVie announced updates from the U.S. Food and Drug Administration and European Medicines Agency for epcoritamab, an investigational T-cell engaging bispecific antibody administered subcutaneously, for relapsed or refractory follicular lymphoma. The FDA has granted Breakthrough Therapy Designation to epcoritamab-bysp for the treatment of adult patients with R/R FL after two or more therapies. Additionally, the EMA has validated a Type II application for epcoritamab for the same indication. If approved, R/R FL would become the second conditionally approved indication for epcoritamab in the European Union. “The FDA granted BTD and validated European application are an important step in our commitment to improving the lives of patients with relapsed/refractory follicular lymphoma, a complex blood cancer with limited treatment options,” said Mariana Cota Stirner, M.D., Ph.D., vice president, therapeutic area head for hematology, AbbVie. “Together with Genmab, we are continuing to investigate epcoritamab as a potential core therapy for multiple B-cell malignancies, including diffuse large B-cell lymphoma and now follicular lymphoma.”