CLR 131 receives fast track designation in lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

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.

Table of Contents

YOU MAY BE INTERESTED IN

Candace S. Johnson leads America’s oldest cancer research center and Jonathan W. Friedberg leads the newest NCI-designated center. Their catchment areas are contiguous, their faculty and staff members collaborate often, and together their institutions embody the culture of NCI-designated cancer centers. 

In the first meeting of the National Cancer Advisory Board since the inauguration of President Donald Trump, NCI Principal Deputy Director Douglas R. Lowy addressed many of the burning questions the oncology field has for the institute. On indirect costs: NCI will continue to use previously negotiated and approved indirect cost rates, with the exception...

The Cancer Letter staff were finalists for nine 2025 Dateline Awards from the Washington, D.C. Chapter of the Society of Professional Journalists—seven for journalism; two for design—and won first place for four. The Cancer Letter’s entries recognized by SPJ include investigative journalism, series, breaking news, features, photojournalism, commentary, illustration, and front page design. This is...

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login