News

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 that 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 approva l for this indication later in 2024.

The CHMP’s opinion follows overall and complete response data from the phase 1/2 EPCOR E 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 obser ved in the pivotal EPCORE NHL-1 diffuse large B-cell ly mphoma (DLBCL) cohort.

Mariana Cota Stirner MD PhD, vice president and therapeutic area head for haematolog y at AbbVie, commented: “Patients with follicular ly mphoma 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 ly mphoma, following failure of other therapies.”

Catherine Thieblemont MD PhD, head of the hemato-oncolog y department, Paris University, Hôpita l Saint-Louis Assistance-Publique-Hopitau x de Paris, both France, added: “Each year, thousands of people in Europe are diagnosed with follicular ly mphoma, and it's an upsetting reality that many of them will experience relapse and refractory disease. Patients deser ve new treatment options, and this positive opinion is the first step to bringing epcoritamab to more patients who need it.”