India, Aug. 6 -- Belgium-headquartered Galapagos NV (GLPG) on Wednesday announced that the FDA has granted Regenerative Medicine Advanced Therapy designation to GLPG5101 for the treatment of relapsed/refractory mantle cell lymphoma, an aggressive subtype of non-Hodgkin lymphoma.
The Regenerative Medicine Advanced Therapy (RMAT) designation, established under the U.S. 21st Century Cures Act, is intended to accelerate development and review of promising cell and gene therapies for serious or life-threatening conditions.
GLPG5101 is currently under a Phase 1/2 multicenter study in patients with relapsed/refractory B-cell non-Hodgkin lymphoma, including follicular lymphoma, marginal zone lymphoma, mantle cell lymphoma, and Diffuse large B-cel...