Galapagos receives FDA RMAT designation for GLPG5101 in R/R mantle cell lymphoma.

Galapagos NV announced that the FDA has granted RMAT designation to GLPG5101, a CAR-T product candidate for relapsed/refractory mantle cell lymphoma. The RMAT designation aims to accelerate development and review of promising cell and gene therapies for serious or life-threatening conditions. GLPG5101 demonstrated preliminary clinical evidence of its potential to treat R/R MCL.

Galapagos NV (Euronext & NASDAQ: GLPG) has received a significant boost in its development efforts for GLPG5101, a second-generation anti-CD19/4-1BB CAR-T product candidate. The United States Food and Drug Administration (FDA) has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to GLPG5101 for the treatment of relapsed/refractory mantle cell lymphoma (R/R MCL) [1].

The RMAT 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. GLPG5101 demonstrated preliminary clinical evidence of its potential to treat R/R MCL, supporting its eligibility for the designation [1].

The clinical data from the ongoing ATALANTA-1 study, which includes a subset of patients with R/R B-cell Non-Hodgkin Lymphoma (B-NHL), including mantle cell lymphoma, played a crucial role in securing the RMAT designation. The study showed high objective and complete response rates, with a manageable safety profile [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 [1]. These advantages could significantly reduce the time it takes for GLPG5101 to reach patients in need.

Galapagos intends to report updated data from the ATALANTA-1 study at a future medical conference, further advancing the understanding of GLPG5101's potential [1].

References:
1. [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