Rare Pediatric Disease Designation granted to neuroblastoma therapy
The U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to 67Cu-SARTATE™, a therapy for the clinical management of neuroblastoma, according to a press release by Clarity Pharmaceuticals.
“The FDA decision to grant RPDD to 67Cu-SARTATE™ for the treatment of neuroblastoma, following an earlier decision to grant it an Orphan Drug Designation, emphasises the critical need for better treatments for this devastating disease, and is testament to the significant level of work we have completed to date on this therapy,” said Dr Alan Taylor, Clarity’s Executive Chairman in the press release. “We are very excited about the development of SARTATE™ in neuroblastoma and are looking forward to the results from our US-based Phase 1/2 trial. We are hoping that the grant of RPDD will get us one step closer to our ultimate goal of developing better treatments for children and adults with cancer.”
Read the full press release here.