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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.
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