Galapagos' GLPG5101 Receives RMAT Designation from US FDA

Galapagos has received RMAT designation from the US FDA for its GLPG5101 candidate for relapsed/refractory indolent NHL patients. The designation was granted based on positive safety data from the ATALANTA-1 study, which demonstrated high complete response and MRD negativity rates with the candidate. The company plans to present new data at EHA and ICML 2025.

Galapagos NV (Euronext & NASDAQ: GLPG) has announced that the United States Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to GLPG5101, a second-generation anti-CD19/4-1BB CAR-T product candidate for the treatment of relapsed/refractory mantle cell lymphoma (R/R MCL). This designation, established under the U.S. 21st Century Cures Act, aims to expedite the development and review of promising cell and gene therapies for serious or life-threatening conditions [1].

The RMAT designation for GLPG5101 is based on preliminary clinical data from the ongoing ATALANTA-1 study, which demonstrated high objective and complete response rates with a manageable safety profile. The study showed low rates of high-grade cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), as well as low dropout rates [1].

The benefits of RMAT designation include increased FDA guidance, more frequent interactions during development, eligibility for accelerated approval based on surrogate or intermediate endpoints, and priority review and rolling submissions. Galapagos plans to present updated data from the ATALANTA-1 study at the European Hematology Association (EHA) and the International Conference on Malignant Lymphoma (ICML) in 2025 [1].

GLPG5101 is a second-generation anti-CD19/4-1BB CAR-T product candidate administered as a single fixed intravenous dose. The ATALANTA-1 Phase 1/2 study is currently enrolling patients in the U.S. and Europe to evaluate the safety, efficacy, and feasibility of decentralized manufacturing of GLPG5101 [1].

Mantle cell lymphoma is a rare and aggressive subtype of non-Hodgkin lymphoma with limited treatment options for patients with relapsed or refractory disease [1]. The RMAT designation for GLPG5101 represents a significant advancement in the treatment landscape for these patients.

References:
[1] https://www.globenewswire.com/news-release/2025/08/06/3128023/0/en/Galapagos-NV-Announces-U-S-FDA-Regenerative-Medicine-Advanced-Therapy-RMAT-Designation-Granted-to-GLPG5101-for-the-Treatment-of-Relapsed-Refractory-Mantle-Cell-Lymphoma.html