CHMP backs AbbVie's Tepkinly for follicular lymphoma

AbbVie has announced that its IgG1-bispecific antibody, Tepkinly (epcoritamab), has been recommended by the European Medicines Agency’s human medicines committee for the treatment of certain cases of follicular lymphoma (FL).

The Committee for Medicinal Products for Human Use (CHMP) has suggested that the drug, developed jointly by AbbVie and Genmab as part of their oncology collaboration, should be granted conditional marketing authorization. This recommendation applies to its use as a monotherapy for adults with relapsed or refractory (R/R) FL who have previously undergone at least two therapies.

The CHMP's endorsement is based on favorable outcomes from the phase 1/2 EPCORE NHL-1 clinical trial, which assessed the safety and efficacy of Tepkinly in more than 120 adults with R/R FL.

Follicular lymphoma is the second most prevalent form of non-Hodgkin lymphoma, representing up to 30% of all cases. The disease is considered incurable, with patients frequently experiencing relapses and a progressively worsening prognosis with each subsequent relapse.

Tepkinly is administered subcutaneously and is designed to bind simultaneously to CD3 on T cells and CD20 on B cells, thereby inducing T-cell-mediated killing of CD20-positive cells.

Mariana Cota Stirner, vice president and therapeutic area head for haematology at AbbVie, highlighted the recurrent nature of FL, noting that patients often face disease recurrence and a shorter duration of response with each successive treatment. She stated, "This positive opinion acknowledges the unmet need in the EU for individuals with R/R FL, following the failure of other therapies."

Earlier this year, AbbVie announced that Tepkinly had been recommended by the National Institute for Health and Care Excellence to treat certain adults with diffuse large B-cell lymphoma (DLBCL). The recommendation applies to patients whose DLBCL has either returned or failed to respond to at least two previous treatments, including Roche’s CD79b-directed antibody-drug conjugate Polivy (polatuzumab vedotin), unless this treatment is contraindicated or not tolerated.

In addition to the European endorsement, AbbVie and Genmab received accelerated approval from the US Food and Drug Administration (FDA) last month for epcoritamab, marketed under the brand name Epkinly, to treat adults with R/R FL.

Commercial responsibilities for epcoritamab are shared by both companies in the United States and Japan, while AbbVie holds the responsibility for further global commercialization.