
Core Insights - Cellectar Biosciences, Inc. has received Breakthrough Therapy Designation from the FDA for iopofosine I 131, a novel cancer targeting agent for relapsed/refractory Waldenstrom macroglobulinemia [2][4] - The Phase 2 CLOVER WaM study reported an overall response rate (ORR) of 83.6% and a major response rate (MRR) of 58.2%, significantly exceeding the primary endpoint of 20% MRR [4][6] - The company is seeking guidance from the European Medicines Agency (EMA) to determine if the Phase 2 data meets the criteria for fast-track, conditional marketing authorization, with an answer expected in late July 2025 [6] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing proprietary drugs for cancer treatment, utilizing its Phospholipid Drug Conjugate™ (PDC) delivery platform [8] - The company's product pipeline includes iopofosine I 131, CLR 121225 targeting solid tumors, and CLR 121125 for other solid tumors, along with various preclinical PDC chemotherapeutic programs [9][10] - iopofosine I 131 has also been studied in Phase 2b trials for multiple myeloma and CNS lymphoma, and the company is eligible for a Pediatric Review Voucher from the FDA upon approval [11]