Cellectar Biosciences has been granted orphan drug designation for its therapeutic, CLR 131, by the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development for the treatment of neuroblastoma, the company announced today.
With the orphan drug designation, Cellectar Biosciences will receive seven-year market exclusivity benefits, increased engagement and assistance from the FDA, tax credits for certain research, research grants and a waiver of the new drug application user fee.
“The FDA’s granting of orphan drug designation for CLR 131 highlights the significant need for new treatments for children with neuroblastoma, and we believe that the targeted delivery of CLR 131 represents a promising novel approach to its treatment,” Cellectar Chief Medical Officer John Friend, M.D., said in a statement.
The FDA considers neuroblastoma an orphan disease as it affects less than 200,000 people nationwide.
CLR 131 is currently being tested in patients with relapsed or refractory multiple myeloma.
One thought on “Cellectar Receives Orphan Drug Designation”