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Lucy Chard
22 May 2023

FDA approves blood cancer therapeutic from AbbVie and Genmab

AbbVie and Genmab recently received approval from the US FDA for their joint venture, the blood cancer therapy epcoritamab, sold under the brand name EPKINLY. 

Epcoritamab is the first therapy of the sort to be approved by the FDA for relapsed or refractory large B-cell lymphoma, under their accelerated approval programme. The treatment is the only T-cell engaging bispecific antibody currently on the market. 

The therapy is used to treat an advanced form of large B-cell lymphoma, a cancer that starts in the lymphatic system affecting B cells, with new cases occuring in 150,000 people worldwide. The patients receiving this therapy must have received at least two previous forms of treatment to be eligible. 

"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," stated Thomas Hudson, Senior Vice President of R&D and Chief Scientific Officer at AbbVie. 

"The approval is just the first step, with our partner Genmab, towards a shared goal of developing a core therapy for patients with B-cell malignancies."

Epcoritamab showed a positive and durable response upon testing, leading to the approval. Approvement further than the accelerated approval will hinge on the results from confirmatory clinical trials. The treatment is currently undergoing Phase III randomised controlled trials to test its use as a mono- or combination therapy in a range of blood cancers. 

AbbVie is working on an expanded oncology portfolio with Genmab, leading to this focus on blood cancers with a view to advance the treatment pipeline. Epcoritamab is the third approval for a blood cancer treatment from AbbVie. 

"Patients with DLBCL who relapse or are refractory to currently available therapies have limited options. Generally, the prognosis for these patients is poor and management of this aggressive disease can be challenging," explained Tycel Phillips, Associate Professor, Department of Hematology & Hematopoietic Cell Transplantation at City of Hope Medical Centre. 

"Epcoritamab is a subcutaneous bispecific antibody that offers an additional treatment option for this patient population. With this approval, patients who are in need of additional therapy may have the opportunity to receive epcoritamab after failure to respond or relapse after two or more systemic therapies."

Source: AbbVie News Center. EPKINLY™ (epcoritamab-bysp) Approved by U.S. FDA as the First and Only Bispecific Antibody to Treat Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL). [Date accessed 22/05/2023]. 

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Lucy Chard
Digital Editor - Pharma

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