EU Panel Approves AbbVie, Regeneron Lymphoma Therapies

A key advisory panel of the European Medicines Agency (EMA) recommended the approval of two CD20xCD3 bispecific antibodies, Tepkinly (epcoritamab) from AbbVie and Genmab, and Regeneron's odronextamab. These drugs are intended for the treatment of certain types of relapsed or refractory lymphoma.

Tepkinly is presently authorized in Europe as a monotherapy for third-line diffuse large B-cell lymphoma (DLBCL). On Friday, the EMA's Committee for Medicinal Products for Human Use (CHMP) issued a favorable opinion for Tepkinly's use in adult patients with follicular lymphoma (FL) who have undergone at least two prior therapies. This recommendation for conditional marketing approval is supported by findings from the Phase I/II EPCORE NHL-1 trial, which demonstrated an overall response rate (ORR) of 82% in 128 patients with relapsed or refractory FL, with a 60% complete response rate.

Mariana Cota Stirner, therapeutic area head for hematology at AbbVie, emphasized the significance of this positive opinion by noting the unmet need for effective treatments for individuals with relapsed or refractory follicular lymphoma in the European Union. In the United States, the drug is marketed under the name Epkinly and received expanded approval for third-line FL earlier this week, in addition to its established indication for DLBCL.

In parallel, Regeneron's odronextamab also gained a positive CHMP opinion for conditional approval in adult patients with FL or DLBCL who have received two or more lines of systemic therapy. This recommendation is based on data from the Phase I ELM-1 and the pivotal Phase II ELM-2 trials. In the ELM-2 trial, odronextamab achieved an ORR of 82%, including a 75% complete response rate, in patients with FL Grades 1 to 3a. For the DLBCL cohort, the drug showed an ORR of 49% in heavily pre-treated patients who had not previously received CAR-T therapy, with 31% achieving a complete response.

The positive opinions from the CHMP are particularly noteworthy for Regeneron, following the U.S. Food and Drug Administration’s (FDA) rejection of odronextamab in March. The FDA's decision was influenced by concerns regarding the enrollment status of confirmatory trials, reflecting the agency's heightened scrutiny of accelerated approvals and the importance it places on the timely completion of post-marketing studies.