Cellectar’s CLR 131 Receives FDA Orphan Drug Designation for the Treatment of Pediatric Osteosarcoma

Cellectar Biosciences (Nasdaq:CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, announces that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation (ODD) to CLR 131, the company’s lead Phospholipid Drug Conjugate (PDC) product candidate, for the treatment of pediatric osteosarcoma, a rare pediatric cancer.

As quoted in the press release:

“Osteosarcoma is the most common type of primary bone cancer occurring most frequently in children. Currently, there are no commercially available drugs for pediatric sarcoma, including osteosarcoma,” said John Friend, M.D., chief medical officer of Cellectar. “This orphan designation for osteosarcoma is the fourth such designation granted by the FDA to CLR 131 for the treatment of rare pediatric cancers in the last six months, and we look forward to evaluating CLR 131 in these deadly and underserved diseases.”

The FDA grants ODD to therapies targeting conditions that affect fewer than 200,000 people in the U.S. The designation provides seven-year market exclusivity, increased engagement and assistance from the FDA, tax credits for certain research, research grants and a waiver of the New Drug Application user fee. In 2018 the FDA also granted CLR 131 orphan drug and rare pediatric disease designations for the treatments of neuroblastoma, rhabdomyosarcoma and Ewing’s sarcoma.

Click here to read the full press release.