Posted by Michael Wonder on 14 Aug 2018
Cellectar’s CLR 131 receives FDA rare paediatric disease designation for the treatment of Ewing’s sarcoma
13 August 2018 - Cellectar Biosciences announces today that the U.S. FDA has granted rare paediatric disease designation to CLR 131, the company’s lead phospholipid drug conjugate product candidate, for the treatment of Ewing’s sarcoma, a rare paediatric cancer.
Since March 2018 the FDA has granted rare paediatric disease designations to CLR 131 for the treatment of three separate rare disease indications including neuroblastoma, rhabdomyosarcoma and now Ewing’s sarcoma. Should CLR 131 be approved by the FDA in any of these indications, the RPDD may enable Cellectar to receive a priority review voucher.
Cellectar plans to evaluate CLR 131 in a Phase 1 clinical study for the treatment of paediatric patients with Ewing’s sarcoma, rhabdomyosarcoma, osteosarcoma, neuroblastoma, high-grade glioma and lymphomas.
