AbbVie and Genmab’s blood cancer therapy, Epkinly (epcoritamab-bysp), has been granted accelerated approval by the US Food and Drug Administration (FDA).
The authorisation specifically applies to adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least two prior lines of treatment.
DLBCL is the most common type of aggressive lymphoma, with approximately 150,000 cases of the disease diagnosed globally each year.
For R/R patients, several targeted therapies including T-cell mediated treatments have recently emerged, the companies said. However, single agent and ready-available or off-the-shelf treatment options are limited.
Epkinly, which is being co-developed by AbbVie and Genmab as part of the companies’ oncology collaboration, is now the first and only T-cell engaging bispecific antibody for this indication.
The FDA’s decision was supported by positive results from a phase 1/2 trial, in which Epkinly delivered an overall response rate of 61%, a complete response rate of 38% and median duration of response of 15.6 months in heavily pretreated R/R DLBCL patients.
Thomas Hudson, senior vice president, research and development, chief scientific officer at AbbVie, said: “DLBCL is an aggressive cancer type that can rapidly progress and resist treatment. The FDA approval of Epkinly represents a new treatment mechanism of action for third line DLBCL patients.
“As a non-chemotherapy, single-agent treatment for DLBCL patients, we hope that Epkinly can effectively treat this aggressive cancer type and can be used for patient care quickly and in an off-the-shelf form for physicians.”
Under the accelerated approval pathway, the companies are now required to conduct studies to confirm the anticipated clinical benefit of Epkinly.
Jan van de Winkel, chief executive officer of Genmab, said: “The approval of Epkinly in the US is an incredibly important milestone for patients with relapsed or refractory DLBCL, who are in need of a new, innovative treatment option administered subcutaneously.”
The partners outlined that they are evaluating Epkinly as a monotherapy, and in combination, across multiple lines of therapy in a range of haematologic malignancies. Both AbbVie and Genmab will share commercial responsibilities in the US and Japan, with AbbVie responsible for further global commercialisation.