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AbbVie, Genmab get FDA approval for blood cancer therapy

AbbVie Inc and Danish drugmaker, Genmab, announced they have got FDA’s approval for a therapy to treat blood cancer in adults who have undergone at least two prior treatments.

HQ Team

May 20, 2023: AbbVie Inc and Danish drugmaker, Genmab, announced they have got FDA’s approval for a therapy to treat blood cancer in adults who have undergone at least two prior treatments.

The epcoritamab therapy, to be sold under the brand name Epkinly, treats cancer that originates in white blood cells.

Epkinly is a prescription medicine used to treat adults with certain types of diffuse large B-cell lymphoma that have relapsed or that did not respond to previous treatment, according to a joint statement.

The patients must have received two or more treatments for their cancer. “Epkinly is approved based on patient response data. A study is ongoing to confirm the clinical benefit of Epkinly. It is not known if Epkinly is safe and effective in children.”

Epkinly is being co-developed by AbbVie and Genmab as part of the companies’ oncology collaboration.


Both companies are evaluating Epkinly as a monotherapy, and in combination, across multiple lines of therapy in a range of hematologic malignancies, according to the statement.

Diffuse large B-cell lymphoma patients are typically treated with chemoimmunotherapy-based regimens.

For relapsed and patients not responding to treatment, several targeted therapies including T-cell mediated treatments have recently emerged. However, single-agent and ready-available or off-the-shelf treatment options are limited.

It is the most common type of aggressive, fast-growing non-Hodgkin’s lymphoma cancer that develops in the lymphatic system, comprising about 30,400 US cases in 2022 and 1accounting for 50,000 new cases each year globally.

The cancer “is an aggressive type that can rapidly progress and resist treatment. The FDA approval of Epkinly represents a new treatment mechanism of action for third-line patients,” said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie.


“As a non-chemotherapy, single-agent treatment for 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,” he said.

 “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.”

Tycel Philips, M.D., City of Hope Associate Professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation, said the FDA approval has opened up new options.

“Patients 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,” he said.

International markets

“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.”

The companies will share commercial responsibilities in the US and Japan, with AbbVie responsible for further global commercialization of Epkinly.

AbbVie will continue to pursue regulatory submissions for epcoritamab across international markets throughout the year, according to the statement.

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, or nearly one in six deaths.

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