Cellectar Biosciences receives RPDD from U.S. FDA for iopofosine I 131

Cellectar Biosciences (CLRB) announced the U.S. Food and Drug Administration, FDA, has granted rare pediatric drug designation, RPDD, for iopofosine I 131 in inoperable relapsed or refractory pediatric high-grade glioma. Iopofosine I 131 is a potential first-in-class, novel cancer targeting agent utilizing a phospholipid ether as a radioconjugate monotherapy. The FDA previously granted Orphan Drug Designation for iopofosine I 131 for the treatment of pHGG. “Receiving Rare Pediatric Disease Designation for iopofosine I 131 underscores its potential to address one of the most devastating cancers affecting children and young adults. Combined with the encouraging interim results from our CLOVER-2 pHGG study, which showed meaningful improvements in progression-free and overall survival, this designation further validates the promise of our targeted radiotherapeutic approach,” stated James Caruso, president and CEO of Cellectar. “We believe iopofosine I 131 represents a compelling opportunity for strategic collaboration to accelerate development and bring a potentially first-in-class therapy to patients who urgently need new options.”