According to a story from Market Screener, the drug company AbbVie recently announced that its investigational therapy epcoritamab has received a positive opinion from the European Union’s Committee for Medicinal Products for Human Use (CHMP). This opinion recommends the approval of a conditional marketing clearance for the drug to be used on its own (a monotherapy) in adult patients living with diffuse large B-cell lymphoma (DLBCL) who have received two prior therapies and whose disease is considered refractory or relapsed.
About Diffuse Large B-Cell Lymphoma
Diffuse large B-cell lymphoma (DLBCL), as the name suggests, is a cancer that affects B cells, which are a type of white blood cell. These cells are responsible for producing antibodies. There is a diverse array of different variants and subtypes of this cancer, and it is the most common form of non-Hodgkin’s lymphoma in adults. Although it can occur in children and young adults in the rarest cases, this type of lymphoma primarily affects older people, usually around 70 or older. Symptoms are typical of many lymphomas, and include night sweats, fatigue, unexpected weight loss, a noticeable mass in the lymph nodes, and fever. Risk factors include underlying immunodeficiencies and infection from the Epstein-Barr virus and Helicobacter pylori. Occasionally, this lymphoma can transform from other types of blood cancer. Treatment includes chemotherapy, rituximab, stem cell transplantation, and immunotherapy; the five-year survival rate is 58 percent. To learn more about diffuse large B-cell lymphoma, click here.
A New Treatment Option in the EU?
Generally, a positive CHMP opinion is a strong positive signal that the drug will ultimately gain approval from the European Commission, a decision which is expected to be made before the end of the year. The opinion follows promising results from a phase 1/2 open label clinical trial. Epcorticamab was able to achieve the study endpoints and is administered subcutaneously. The drug has previously been approved by the US Food and Drug Administration (FDA) under Accelerated Approval protocols.
Diffuse large B-cell lymphoma can be an aggressive cancer and when it becomes refractory (treatment resistant) or relapses, therapy options are limited. The approval of this drug would offer EU citizens an additional treatment option when others have failed.
