AbbVie has announced that its IgG1-bispecific antibody Tepkinly (epcoritamab) has been recommended by the European Medicines Agency’s human medicines committee to treat specific cases of follicular lymphoma (FL).
The Committee for Medicinal Products for Human Use (CHMP) has recommended that the drug, which is being co-developed by AbbVie and Genmab as part of the companies’ oncology collaboration, be granted conditional marketing authorisation as a monotherapy for adults with relapsed or refractory (R/R) FL who have received at least two prior therapies.
The CHMP’s recommendation of the therapy was supported by positive results from the phase 1/2 EPCORE NHL-1 clinical trial, which evaluated the safety and efficacy of Tepkinly in more than 120 adults with R/R FL.
FL is the second-most common form of non-Hodgkin lymphoma, accounting for up to 30% of all cases. The disease is considered incurable, with patients frequently relapsing and the prognosis worsening after each subsequent relapse.
Administered subcutaneously, Tepkinly is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induce T-cell-mediated killing of CD20-positive cells.
Mariana Cota Stirner, vice president, therapeutic area head for haematology at AbbVie, said: “Patients with FL are likely to face disease recurrence and shorter durability of response with each subsequent line of treatment.
“This positive opinion recognises the unmet need in the EU for individuals with R/R FL, following failure of other therapies.”
AbbVie announced earlier this year 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 agency’s decision specifically applies to patients who have DLBCL that has returned or not responded to at least two previous treatments, including Roche’s CD79b-directed antibody-drug conjugate Polivy (polatuzumab vedotin), unless this is contraindicated or not tolerated.
AbbVie and Genmab also received accelerated approval by the US Food and Drug Administration (FDA) last month for epcoritamab, under the brand name Epkinly, to treat adults with R/R FL.
Both companies share commercial responsibilities for epcoritamab in the US and Japan, while AbbVie is responsible for further global commercialisation.