07.09.19
Cellectar Biosciences, Inc. was granted Fast Track Designation by the FDA for CLR 131 in relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL).
CLR 131 is the company’s small-molecule, cancer-targeting radiotherapeutic Phospholipid Drug Conjugate™ (PDC™) designed to deliver cytotoxic radiation directly and selectively to cancer cells and cancer stem cells. It is currently being evaluated in Cellectar’s ongoing Phase 2 CLOVER-1 clinical study in patients with relapsed or refractory select B-Cell lymphomas.
“We are pleased to receive FDA’s Fast Track Designation for CLR 131. 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,” said James Caruso, president and CEO of Cellectar. “As announced last year, data from the DLBCL cohort in our ongoing CLOVER-1 trial showed an encouraging 33% overall response rate at the time of the interim assessment. Patients prior to the interim assessment received a single 25.0 mCi/m2 dose of CLR 131. Dosing in the Phase 2 CLOVER-1 study has increased, and patients are now receiving 37.50 mCi/m2 fractionated in two administrations of CLR 131. 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.”
CLR 131 is the company’s small-molecule, cancer-targeting radiotherapeutic Phospholipid Drug Conjugate™ (PDC™) designed to deliver cytotoxic radiation directly and selectively to cancer cells and cancer stem cells. It is currently being evaluated in Cellectar’s ongoing Phase 2 CLOVER-1 clinical study in patients with relapsed or refractory select B-Cell lymphomas.
“We are pleased to receive FDA’s Fast Track Designation for CLR 131. 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,” said James Caruso, president and CEO of Cellectar. “As announced last year, data from the DLBCL cohort in our ongoing CLOVER-1 trial showed an encouraging 33% overall response rate at the time of the interim assessment. Patients prior to the interim assessment received a single 25.0 mCi/m2 dose of CLR 131. Dosing in the Phase 2 CLOVER-1 study has increased, and patients are now receiving 37.50 mCi/m2 fractionated in two administrations of CLR 131. 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.”
