FDA News

FDA grants fast track designation to CLR 131 for diffuse large B-cell lymphoma

The FDA granted fast track designation to CLR 131 for treatment of relapsed or refractory diffuse large B-cell lymphoma.

CLR 131 (Cellectar Biosciences) is a small-molecule, targeted phospholipid-drug conjugate designed to deliver cytotoxic radiation to cancer cells and cancer stem cells while minimizing exposure to healthy cells.

“We are pleased to receive FDA’s fast track designation for CLR 131,” James Caruso, president and CEO of Cellectar Biosciences, said in a company-issued press release. “This designation supports our efforts to more rapidly provide a new therapeutic option for patients with relapsed or refractory DLBCL, a disease that typically has a very poor prognosis and low rates of survival.”

The phase 2 CLOVER-1 study is designed to evaluate the agent as treatment for up to 80 patients with relapsed or refractory select B-cell hematologic malignancies, including DLBCL, mantle cell lymphoma, marginal zone lymphoma, multiple myeloma, and chronic lymphocytic leukemia/small lymphocytic lymphoma.

Clinical benefit rate is the primary endpoint. Additional endpoints include overall response rate, PFS and OS.

At interim assessment, researchers reported a 33% ORR in the DLBCL cohort.

“We are optimistic that CLR 131 has the potential to provide a meaningful treatment option for these patients and look forward to additional data in 2019,” Caruso said.

The FDA granted fast track designation to CLR 131 for treatment of relapsed or refractory diffuse large B-cell lymphoma.

CLR 131 (Cellectar Biosciences) is a small-molecule, targeted phospholipid-drug conjugate designed to deliver cytotoxic radiation to cancer cells and cancer stem cells while minimizing exposure to healthy cells.

“We are pleased to receive FDA’s fast track designation for CLR 131,” James Caruso, president and CEO of Cellectar Biosciences, said in a company-issued press release. “This designation supports our efforts to more rapidly provide a new therapeutic option for patients with relapsed or refractory DLBCL, a disease that typically has a very poor prognosis and low rates of survival.”

The phase 2 CLOVER-1 study is designed to evaluate the agent as treatment for up to 80 patients with relapsed or refractory select B-cell hematologic malignancies, including DLBCL, mantle cell lymphoma, marginal zone lymphoma, multiple myeloma, and chronic lymphocytic leukemia/small lymphocytic lymphoma.

Clinical benefit rate is the primary endpoint. Additional endpoints include overall response rate, PFS and OS.

At interim assessment, researchers reported a 33% ORR in the DLBCL cohort.

“We are optimistic that CLR 131 has the potential to provide a meaningful treatment option for these patients and look forward to additional data in 2019,” Caruso said.