BRIEF—Cellectar gets Rare Pediatric Disease designation for CLR 131

The US Food and Drug Administration has granted rare pediatric disease designation (RPDD) to Cellectar Biosciences’ lead phospholipid drug conjugate, CLR 131, for the treatment of neuroblastoma.

“Neuroblastoma is a devastating cancer most often found in infants and young children. The grant of RPDD for CLR 131 in conjunction with the orphan drug designation we received in March highlight the critical need for new treatments in the fight against this disease,” said John Friend, chief medical officer of Cellectar.

“We look forward to working with the FDA to bring this potential therapy to pediatric patients and expect to begin a clinical study in neuroblastoma during the second half of 2018,” he added.

RPDD provides for the issuance of a rare pediatric disease priority review voucher following FDA approval.

The voucher can be use for accelerated approval of a future application or it can be sold to a third party.