FDA grants CLR 131 Fast Track designation for the treatment of patients with relapsed or refractory DLBCL

On 9 July 2019, CLR 131, an investigational small-molecule radio-therapeutic, was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL)¹. CLR 131 is a phospholipid drug conjugate that selectively kills cancer cells by delivering cytotoxic radiation.

The Fast Track designation was based on the positive results from a multicenter phase II clinical trial (NCT02952508) CLOVER-1, which is evaluating the efficacy and safety of CLR 131 in R/R B-cell hematologic cancers. The interim assessment of the trial showed the overall response rate of 33%². The topline data report is expected later this year.

CLR 131 is also being evaluated in phase I studies in pediatric solid tumors and lymphoma, as well as multiple myeloma (MM)³. Earlier CLR 131 was granted Orphan Drug designation for the treatment of MM, neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma, and osteosarcoma.