AbbVie’s Tepkinly gains positive CHMP opinion for follicular lymphoma treatment

Betsy Goodfellow | June 28, 2024 | News story | Medical Communications AbbVie, CHMP, EMA, Oncology, follicular lymphoma 

AbbVie has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion to Tepkinly (epcoritamab), recommending the conditional marketing authorisation of the drug as a monotherapy treatment for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL).

The drug is the first and only T-cell engaging bispecific antibody which is administered subcutaneously for this indication, after patients have had two or more prior therapies.

The European Commission is expected to decide on the drug’s approval for this indication later in 2024.

The CHMP’s opinion follows overall and complete response data from the phase 1/2 EPCORE NHL-1 clinical trial, which assessed the drug in 128 patients with R/R FL after two or more prior therapies.

Tepkinly’s safety profile remained consistent with that observed in the pivotal EPCORE NHL-1 diffuse large B-cell lymphoma (DLBCL) cohort.

Mariana Cota Stirner MD PhD, vice president and therapeutic area head for haematology at AbbVie, commented: “Patients with follicular lymphoma 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 relapsed or refractory follicular lymphoma, following failure of other therapies.”

Betsy Goodfellow

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