This article has been reviewed according to Science X's editorial process and policies. Editors have highlighted the following attributes while ensuring the content's credibility:


reputable news agency


Epkinly granted accelerated FDA approval for lymphoma treatment

Epkinly granted accelerated FDA approval for lymphoma

The U.S. Food and Drug Administration has granted accelerated approval for Genmab's Epkinly (epcoritamab-bysp) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma.

The recommended regimen consists of Epkinly administered subcutaneously in 28-day cycles until or unacceptable toxicity. Step-up dosing is recommended with cycle 1 (0.16 mg on day 1; 0.8 mg on day 8; and 48 mg on day 15 and day 22), followed by fixed dosing of 48 mg weekly dosing during cycles 2 through 3, every other week during cycle 4 through 9, and then every four weeks on day 1 of subsequent cycles.

Approval was based on trial data from 148 patients with relapsed or refractory DLBCL. The overall response rate, assessed by an independent review committee, was 61%, with 38% of patients achieving complete responses. During a median follow-up of 9.8 months among responders, the estimated median duration of response was 15.6 months.

The prescribing information has a boxed warning for serious or life-threatening cytokine release syndrome (CRS) and life-threatening or fatal immune effector cell-associated neurotoxicity syndrome. Infections and cytopenias are included as warnings and precautions. The most common (≥20%) adverse reactions were CRS, fatigue, musculoskeletal pain, injection site reactions, pyrexia, abdominal pain, , and diarrhea, while the most common grade 3 to 4 laboratory abnormalities (≥10%) included decreases in , neutrophil count, white blood cell count, hemoglobin, and platelets.

More information: More Information

Copyright © 2023 HealthDay. All rights reserved.

Citation: Epkinly granted accelerated FDA approval for lymphoma treatment (2023, May 23) retrieved 23 September 2023 from
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.

Explore further

Mivavotinib for relapsed/refractory B-cell lymphoma


Feedback to editors