Home Alzheimer’s Disease FDA Grants Fast Track Designation for CLR 131 in LPL/WM

FDA Grants Fast Track Designation for CLR 131 in LPL/WM

The FDA has granted fast track designation for CLR 131 in lymphoplasmacytic lymphoma (LPL)/Waldenstrom’s macroglobulinemia (WM) in patients having received 2 prior treatment regimens or more, according to Cellectar Biosciences, the developer of the agent.1

CLR 131 is a small-molecule, cancer-targeting radiotherapeutic Phospholipid Drug Conjugate (PDC) designed to deliver cytotoxic radiation directly and selectively to cancer cells and cancer stem cells. Currently, CLR 131 is being evaluated in the company’s ongoing phase II CLOVER-1 clinical study in patients with relapsed or refractory multiple myeloma and LPL/WM.

“LPL/WM patients that do not respond optimally or are intolerant of ibrutinib, currently have limited treatment options and poor survival rates,” James Caruso, president and CEO of Cellectar, said in a press release. “Fast Track Designation for LPL/WM further…

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