FDA Approves AbbVie’s Bispecific Antibody for Treating Lymphoma

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FDA has approved AbbVie’s EPKINLY (epcoritamab-bysp), a bispecific antibody for treating relapsed or refractory diffuse large B-cell lymphoma.

AbbVie announced on May 19, 2023 that FDA has approved EPKINLY (epcoritamab-bysp), a T-cell engaging bispecific antibody for treating relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The bispecific is particularly indicated for treating adult patients with R/R DLBCL, not otherwise specified, including DLBCL arising from indolent lymphoma and high-grade B–cell lymphoma (HGBL). Administration of the bispecific is intended for patients who have already had two or more lines of systemic therapies.

According to a company press release, DLBCL patients are typically treated with chemoimmunotherapy-based regimens, but several targeted therapies, including T-cell mediated treatments, have recently emerged for R/R patients. A single agent and ready-available or off-the-shelf treatment options, however, remain limited.

"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,” said Thomas Hudson, senior vice-president, research and development, chief scientific officer, AbbVie, in the press release. “As a non-chemotherapy, single-agent treatment for DLBCL patients, we hope that [epcoritamab-bysp] can effectively treat this aggressive cancer type and can be used for patient care quickly and in an off the shelf form for physicians."

"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," said Tycel Phillips, City of Hope associate professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation, in the release. "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."


AbbVie co-developed epcoritamab-bysp with partner Genmab as part of an oncology collaboration between the companies.

Source: AbbVie