Cellectar Biosciences announced today that the U.S. Food and Drug Administration has granted rare pediatric disease designation (RPDD) to its phospholipid drug conjugate, CLR 131, for the treatment of neuroblastoma.
“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,” Cellectar Chief Medical Officer John Friend, M.D., said in a statement.
According to a release, the FDA grants RPDD for diseases that primarily affect children from birth to 18 years old and affect fewer than 200,000 persons in the United States. If CLR 131 is approved by the FDA, the RPDD could let Cellectar receive a priority review voucher, reducing the FDA review time from 12 months to six.