FDA Grants RMAT Designation to Galapagos’ CAR-T Therapy for Mantle Cell Lymphoma

The U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to Galapagos NV's GLPG5101, a second-generation anti-CD19/4-1BB CAR-T therapy for relapsed/refractory mantle cell lymphoma (R/R MCL), an aggressive B-cell non-Hodgkin lymphoma subtype. This designation, established under the 21st Century Cures Act, enables accelerated development and regulatory review by providing increased FDA guidance, more frequent interactions, eligibility for accelerated approval based on surrogate endpoints, and benefits such as priority review and rolling submissions. GLPG5101 demonstrated high objective and complete response rates along with a manageable safety profile in the ongoing phase 1/2 ATALANTA-1 trial, which includes patients with multiple B-cell NHL subtypes. The therapy also features a decentralized manufacturing platform that reduces vein-to-vein time to seven days, potentially offering advantages over existing CAR-T therapies like Breyanzi and Tecartus. Galapagos emphasizes that the RMAT status will facilitate closer collaboration with the FDA, allowing faster development and assessment timelines to bring an effective treatment option to patients with limited alternatives. The designation is viewed as a significant step in positioning GLPG5101 competitively in the evolving oncology market.