FDA Approves Epkinly for Treatment of Advanced Diffuse Large B-Cell Lymphoma

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The FDA has granted early approval to epcolitamab-bysp for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma, according to the drug’s manufacturer.

This indication applies to the use of TAGRISSO by adults with unspecified DLBCL (including DLBCL arising from indolent lymphoma and high-grade B-cell lymphoma after two or more lines of systemic therapy). Full approval for this indication depends on further confirmation of clinical benefits through confirmatory clinical trials.

General FDA news infographic

“Despite recent advances in the treatment of advanced DLBCL, due to the progressiveness and complexity of the disease, there is still a need for new options that produce remission, are well tolerated, and can be administered at the time of relapse. increase.” Megan Gutierrez Lymphoma Research Foundation CEO said in a press release issued by Genmab. “Epkinly’s approval offers new options—and with it, new hope—for patients and the broader lymphoma community.”

Epcoritamab-bysp (Epkinly; Genmab, AbbVie) — a submission previously granted FDA Priority Review status — is the first T-cell binding bispecific antibody FDA approved for use in adults with relapsed or refractory DLBCL is. The drug uses his Genmab’s proprietary DuoBody technology, designed to simultaneously bind CD3 on T cells and CD20 on B cells, inducing T-cell-mediated killing of CD20-positive cells. It has been.

“Patients with DLBCL who have relapsed or are refractory to currently available therapies have limited options. In general, the prognosis for these patients is poor, making management of this progressive disease difficult. may become.” Tysel Phillipsmedical doctor, An associate professor of hematology and hematopoietic cell transplantation at City of Hope said in a release. “Epcolitamab is a subcutaneous bispecific antibody that offers an additional therapeutic option for this patient population.”

The FDA approved epcolitamab-bysp based on results from the phase 2 EPCORE NHL-1 trial evaluating the safety and efficacy of subcutaneous epcolitamab in patients with relapsed, advanced, or refractory CD20-positive DLBCL.

Results showed an overall response rate of 61% (95% CI, 52.5-68.7) in patients treated with this regimen, of which 38% (95% CI, 30-46.2) achieved a complete remission. Indicated. The investigators reported a median duration of response to treatment of 15.6 months (95% CI, 9.7 to not reached).

Boxed warning mentions the possibility of cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome. These two life-threatening treatment-related toxicities are known to occur in some patients after administration of epcolitamab bysp.


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