CLR 131 was granted FDA Fast Track Designation in lymphoplasmacytic lymphoma (LPL)/Waldenstrom’s macroglobulinemia in patients having received two prior treatment regimens or more.
CLR 131 is sponsored by Cellectar Biosciences Inc.
CLR 131 is a small-molecule, cancer-targeting radiotherapeutic Phospholipid Drug Conjugate designed to deliver cytotoxic radiation directly and selectively to cancer cells and cancer stem cells. It is being evaluated in Cellectar’s phase II CLOVER-1 clinical study in patients with relapsed or refractory multiple myeloma and lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia.
“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 statement.
All four LPL/WM patients treated in our CLOVER-1 phase II study to date achieved a 100% overall response rate and a 25% complete response rate.
“This strong response rate may represent an important improvement in the treatment of relapsed/refractory LPL/WM as no approved or late-stage development treatments for relapsed or refractory patients have reported complete responses,” Caruso said.
FDA granted CLR 131 in LPL Orphan Drug Designation earlier this year.
