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Galapagos Secures the US FDA’s RMAT Designation for GLPG5101 to Treat R/R Mantle Cell Lymphoma

Shots:

  • The US FDA has granted RMAT designation to GLPG5101 for the r/r mantle cell lymphoma (MCL)
  • Designation was supported by P-I/II (ATALANTA-1) trial assessing GLPG5101 [50×106 (DL1), 110×106 (DL2) & 250×106 (DL3)] in r/r B-cell Non-Hodgkin Lymphoma pts, incl. those with MCL
  • Trial demonstrated superior ORR & CR rate as well as favorable safety profile, with low rates of high-grade CRS, ICANS, & minimal dropout; further data to be shared in future

Ref: Galapagos | Image: Galapagos | Press Release

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