FDA Grants Rare Pediatric Disease Designation to Cellectar Biosciences’ CLR 131 for the Treatment of Rhabdomyosarcoma

Cellectar Biosciences (Nasdaq:CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, announces today that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to CLR 131, the company’s lead Phospholipid Drug Conjugate™ (PDC) product candidate, for the treatment of rhabdomyosarcoma, a rare pediatric cancer.

As quoted in the press release:

“There is a critical need for new therapies in the fight against deadly diseases such as rhabdomyosarcoma and we continue to increase our focus on delivering innovative solutions to patients suffering from such rare cancers,” said John Friend, M.D., chief medical officer of Cellectar. “The grant of a second RPDD represents an additional regulatory milestone for CLR 131 and we look forward to working with the FDA to advance development of CLR 131 as rapidly as possible, to fully evaluate its potential as a therapeutic option for rhabdomyosarcoma.”

Last month, Cellectar announced that the FDA also granted RPDD for CLR 131 for the treatment of neuroblastoma. If CLR 131 is approved by the FDA for either neuroblastoma or rhabdomyosarcoma, the rare pediatric disease designation may enable Cellectar to receive a priority review voucher. Priority review vouchers can be used by the sponsor to receive priority review for a future NDA or BLA submission, which would reduce the FDA review time from 12 months to six months. Currently, these vouchers can also be transferred or sold to another entity. Over the last 16 months, five priority review vouchers were sold for between $110 million to $150 million each.

Click here to read the full press release.