FDA Approves EPKINLY (Epcoritamab-Bysp) for Relapsed or Refractory Follicular Lymphoma

1. FDA Approval: The U.S. Food and Drug Administration (FDA) has approved EPKINLY (epcoritamab-bysp) for the treatment of adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
2. First and Only Bispecific Antibody: EPKINLY is the first and only T-cell engaging bispecific antibody approved in the U.S. to treat both relapsed or refractory follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
3. Subcutaneous Treatment: EPKINLY is administered subcutaneously, offering a convenient treatment option without mandatory hospitalization.
4. EPCORE NHL-1 Study: The approval is based on results from the Phase 1/2 EPCORE NHL-1 study, which demonstrated durable and clinically meaningful treatment responses in patients with relapsed or refractory FL.
5. Safety Profile: Common adverse events include injection site reactions, cytokine release syndrome, COVID-19, fatigue, upper respiratory tract infections, musculoskeletal pain, rash, diarrhea, fever, cough, and headache. The prescribing information includes a Boxed Warning for serious or life-threatening cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome.
6. Ongoing Clinical Development: EPKINLY is being evaluated in ongoing clinical trials as a monotherapy and in combination across lines of therapy in various hematologic malignancies.