The Food and Drug Administration granted CLR 131, a targeted, molecular radiotherapy, a fast track designation.
Patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) could soon have a new therapy option. The Food and Drug Administration (FDA) granted Fast Track Designation to CLR 131, a targeted, molecular radiotherapy. Cellectar Biosciences, Inc., the maker of the therapy, made the announcement today.
CLR 131 is a small-molecule, targeted phospholipid drug conjugate that delivers cytotoxic radiation directly to cancer cells to help limit exposure to healthy cells. The FDA’s decision to give the therapy a Fast Track designation could accelerate the development of CLR 131 and expedite the review process with the potential to approve the therapy.
“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,” James Caruso, president and CEO of Cellectar, said in a press release.
Researchers are currently investigating CLR 131 in three clinical trials for different types of blood cancers. There are two phase 1 trials — one in relapsed or refractory multiple myeloma and another in pediatric solid tumors and lymphoma. A phase 2 trial, CLOVER-1, involves patients with select types of relapsed or refractory B-cell lymphomas, including multiple myeloma, chronic lymphocytic leukemia/small lymphocytic lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma, mantle cell lymphoma and DLBCL.
Up to 80 patients will be enrolled in the trial from 10 leading cancer centers across the country. Clinical benefit response, overall response rate, progression free survival, median overall survival, as well as other markers of efficacy are being examined. Last year, an overall response rate of 33% was seen in the group of patients with DLBCL during an 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,” Caruso said.
CLR 131 was granted Orphan Drug designation for the treatment of multiple myeloma in 2014 and, in 2018, was granted Orphan Drug and Rare Pediatric Disease designation for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. In May, CLR 131 was given Fast Track designation for the fourth line or later treatment of relapsed or refractory multiple myeloma.