New FDA Approval Expands Use of Epkinly for Follicular Lymphoma

EPKINLY, used with rituximab and lenalidomide (EPKINLY + R2), is now an FDA approved option for people with follicular lymphoma whose disease has come back or stopped responding to earlier treatment; in a large phase 3 study, it helped patients live longer without their disease worsening and led to higher response rates than R2 alone,…

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Home » Non Hodgkins Lymphoma » New FDA Approval Expands Use of Epkinly for Follicular Lymphoma

The FDA has approved a new treatment option called epcoritamab-bysp (Epkinly) for adults with follicular lymphoma that has come back or not responded to prior treatment. Epkinly can now be used together with rituximab and lenalidomide (often called “R²”) for relapsed or refractory follicular lymphoma, and it also has full (traditional) approval as a single agent for people who have already received at least two lines of systemic therapy.​

In the EPCORE FL-1 study of 488 patients, adding epcoritamab to R² helped people live longer without their disease getting worse (progression-free survival) and led to more patients having their lymphoma shrink compared with R² alone, with a response rate of 89% versus 74%. However, Epkinly can cause serious side effects, including cytokine release syndrome (CRS), neurologic effects called ICANS, infections, and low blood counts, so patients should talk with their care team about how this medicine is given, how they will be monitored, and whether it is appropriate for their situation.​

About Epcoritamab (Epkinly)

Epcoritamab is the first T-cell–engaging bispecific antibody approved by the FDA for the treatment of adults with R/R diffuse large B-cell lymphoma and follicular lymphoma after 2 or more lines of treatment.Epcoritamab is a IgG1-bispecific antibody designed to direct cytotoxic T cells selectively to the lymphoma to elicit an immune response toward the malignant cells. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells and induces T cell mediated killing of lymphoma B cells.

Reference

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-epcoritamab-bysp-follicular-lymphoma-indications

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