Belgian biotechnology company Galapagos NV (Euronext Brussels:GLPG) (NASDAQ:GLPG) announced on Wednesday that it has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the US Food and Drug Administration for GLPG5101, its second-generation anti-CD19/4-1BB CAR-T candidate for relapsed/refractory mantle cell lymphoma.

This designation is based on data from the ongoing ATALANTA-1 study, which showed high objective and complete response rates, along with a manageable safety profile including low incidence of high-grade cytokine release syndrome and neurotoxicity.

RMAT designation is intended to expedite the development and review of cell and gene therapies for serious conditions and provides benefits such as priority review, rolling submissions, and accelerated approval pathways.

Patients with relapsed or refractory mantle cell lymphoma have limited treatment options, making GLPG5101 a potential therapeutic advancement in this high-need area.

Galapagos will benefit from increased FDA interaction, early discussions on potential endpoints, and all Fast Track and Breakthrough Therapy advantages such as priority review and rolling submissions.

The company continues to advance GLPG5101 as part of its cell therapy pipeline targeting difficult-to-treat hematologic cancers.