FDA approves Epkinly for treatment of advanced diffuse large B-cell lymphoma
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The FDA granted accelerated approval to epcoritamab-bysp for treatment of adults with relapsed or refractory diffuse large B-cell lymphoma, according to the agent’s manufacturer.
The indication applies to use of the agent by adults with DLBCL not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade Bcell lymphoma after two or more lines of systemic therapy. Full approval for the indication is dependent on further confirmation of clinical benefit via confirmatory clinical trials.
"Despite recent advances in treating advanced DLBCL, due to the aggressive nature and complexity of the disease there remains a need for new options that can provide remission, are tolerable and can be administered upon relapse,” Meghan Gutierrez, CEO of Lymphoma Research Foundation, said in a Genmab-issued press release. “The approval of Epkinly brings a new option — and with it — new hope to patients and the greater lymphoma community.”
Epcoritamab-bysp (Epkinly; Genmab, AbbVie) — the application for which previously received FDA priority review status — is the first T-cell-engaging bispecific antibody the agency approved for use in adults with relapsed or refractory DLBCL. The agent uses Genmab’s proprietary DuoBody technology and is designed to bind simultaneously to CD3 on T cells and CD20 on B cells, inducing T cell-mediated killing of CD20-positive cells.
“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,” Tycel Phillips, MD, associate professor in the department of hematology and hematopoietic cell transplantation at City of Hope, said in the release. “Epcoritamab is a subcutaneous bispecific antibody that offers an additional treatment option for this patient population.”
FDA approved epcoritamab-bysp based on results of the phase 2 EPCORE NHL-1 trial evaluating the safety and efficacy of subcutaneous epcoritamab in patients with relapsed, progressive or refractory CD20-positive DLBCL.
Results showed a overall response rate of 61% (95% CI, 52.5-68.7) among those treated with the therapy, including 38% (95% CI, 30-46.2) who achieved a complete remission. Researchers reported a median 15.6-month (95% CI, 9.7 to not yet reached) duration of response to therapy.
A boxed warning states the possibility of cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome — two life-threatening treatment-related toxicities known to occur in some patients after administration of epcoritamab-bysp.
References:
- Epkinly (prescribing information); Genmab; Plainsboro, NJ; 2023.
- Genmab. Epkinly (epcoritamab-bysp) approved by U.S. Food and Drug Administration as the first and only bispecific antibody to treat adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) (press release). Available at: https://ir.genmab.com/news-releases/news-release-details/epkinlytm-epcoritamab-bysp-approved-us-food-and-drug. May 19, 2023. Accessed May 19, 2023.
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