The US Food and Drug Administration (FDA) has 鈥檚 Biologics License Application (BLA) of epcoritamab (DuoBody-CD3xCD20) to treat adults with relapsed/refractory (r/r) large B-cell lymphoma (LBCL), for priority review.
Epcoritamab is intended for usage in such patients following two or more lines of systemic therapy.
The BLA is backed by data from the LBCL cohort of the open-label, multicentre Phase I/II EPCORE NHL-1 clinical trial of subcutaneous epcoritamab.
The trial analysed the safety and initial efficacy of the therapy in adults with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin鈥檚 lymphoma (NHL), including LBCL and diffuse large B-cell lymphoma (DLBCL).
An investigational IgG1-bispecific antibody, epcoritamab attaches to CD3 on T-cells and CD20 on B-cells at the same time to elicit T-cell-facilitated CD20+ cells鈥� destruction.
Under an oncology partnership, and are jointly developing the therapy.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataCommercial responsibilities in the US and Japan will be shared by the parties while AbbVie will oversee epcoritamab鈥檚 marketing globally.
Two Phase III trials are underway analysing epcoritamab as a single agent for r/r DLBCL as well as epcoritamab combination in r/r follicular lymphoma patients, respectively.
AbbVie global oncology development vice-president and head Mohamed Zaki said: 鈥淲e are committed to the research and development of innovative therapies to provide important treatment options for people living with blood cancer such as large B-cell lymphoma, which has limited treatment options in the relapsed/refractory setting.
鈥淭his milestone signals an early step in our hope to develop a core therapy for people living with B-cell malignancies.鈥�
In October this year, the European Medicines Agency validated the company鈥檚 Marketing Authorization Application for epcoritamab to treat relapsed/refractory (r/r) DLBCL in adults following two or more lines of systemic treatment.
