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FDA Approves new Sub-q Tx for DLBCL – Epkinly

The FDA recently approved a new subcutaneous therapy, Epkinly (epcoritamab-bysp) from Genmab, for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including those with DLBCL arising from indolent lymphoma or high-grade B-cell lymphoma. DLBCL is a form of non-Hodgkin lymphoma.

DLBCL is an aggressive cancer type that can rapidly progress and resist treatment. The FDA approval of (Epcoritamab) represents a new treatment mechanism of action for third line DLBCL patients. DLBCL is fast-growing and the most common type of lymphoma accounting for 30,400 new cases in the United States each year.

Epkinly was approved with a boxed warning for Cytokine Release Syndrome and Immune Effector Cell-Associated Neurotoxicity Syndrome. Further, the package insert specifies a timed induction schedule over the first month with as dosage is increased. As such, the label also specifies that the therapy must be administered by a trained healthcare professional to monitor for adverse reactions especially over the first three months. 

The company confirmed pricing for Epkinly at $37,500 per month, based on an average length of therapy of around nine months but, indicated that monthly price should decrease after nine months due to less frequent dosing.

Distribution details were not announced. As the therapy must be administered by a health care professional, it is assumed that Epkinly will likely be available through specialty pharmacy distribution.

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