EU Approves AbbVie’s TEPKINLY for Relapsed Follicular Lymphoma

The authorization follows the pivotal Phase 3 EPCORE FL-1 trial, which compared the new combination regimen against the standard of care. Data from the study revealed that patients receiving the TEPKINLY-based therapy experienced a 79% reduction in the risk of disease progression or death. Overall response rates reached 96% in the treatment group, with 74% of patients achieving a complete response, significantly outperforming the 43% complete response rate observed in the control group.

Catherine Thieblemont, head of the hemato-oncology department at Hôpital Saint-Louis in Paris, noted that the results offer a meaningful shift in the treatment paradigm for a disease that remains incurable and prone to cycles of relapse. While the trial demonstrated high efficacy, the safety profile remained consistent with the known risks of the individual components. Common adverse reactions included neutropenia, fatigue, and cytokine release syndrome, with serious adverse reactions reported in 44% of patients during the study. AbbVie and its partner Genmab continue to evaluate the therapy across various hematologic malignancies to further address the clinical needs of patients facing difficult-to-treat lymphomas.