Galapagos NV Receives U.S. FDA RMAT Designation for GLPG5101 in Relapsed/Refractory Mantle Cell Lymphoma
Thursday, August 07, 2025
Galapagos NV has announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its CAR-T therapy candidate GLPG5101. This second-generation anti-CD19/4-1BB CAR-T product is being developed for the treatment of relapsed or refractory mantle cell lymphoma (R/R MCL).
The RMAT designation, introduced under the U.S. 21st Century Cures Act, is intended to speed up the development and review process for promising cell and gene therapies targeting serious or life-threatening conditions. GLPG5101 received this designation based on early clinical evidence suggesting potential to modify or treat R/R MCL.
The decision was supported by data from the ongoing ATALANTA-1 study, which includes patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma (B-NHL), including a subset with mantle cell lymphoma. Results from the study showed encouraging objective and complete response rates, along with a manageable safety profile. Low rates of high-grade cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and minimal dropout rates were reported.
RMAT designation provides several benefits, such as increased guidance and regular interactions with the FDA, the possibility of accelerated approval based on surrogate or intermediate endpoints, as well as all advantages of Fast Track and Breakthrough Therapy status—including priority review and rolling submissions.
Galapagos plans to present updated data from the ATALANTA-1 trial at an upcoming medical conference.
GLPG5101 is given as a single, fixed intravenous dose. It is currently being evaluated in a Phase 1/2 study across eight haematological cancers with significant unmet medical needs. The Phase 1 part of the study focuses on safety and determining the appropriate dose for Phase 2. The dose levels assessed include 50×10⁶ (DL1), 110×10⁶ (DL2), and 250×10⁶ (DL3) CAR-positive viable T-cells. Secondary Phase 1 objectives include measuring initial effectiveness and assessing the feasibility of decentralised manufacturing.
Phase 2 aims to evaluate the overall objective response rate, with further endpoints including complete response rate, duration of response, progression-free survival, overall survival, safety, pharmacokinetics, and decentralised manufacturing feasibility. All participants in the study will be monitored for up to 24 months.
Patient recruitment for the ATALANTA-1 study is currently ongoing in the United States and Europe.
Source: globenewswire.com
