FDA News

FDA grants orphan drug designation to CLR 131 for lymphoplasmacytic lymphoma

The FDA granted orphan drug designation to CLR 131 for treatment of lymphoplasmacytic 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.

The ongoing phase 2 CLOVER-1 trial is evaluating CLR 131 for treatment of patients with relapsed or refractory B-cell lymphomas, including lymphoplasmacytic lymphoma, a rare form of non-Hodgkin lymphoma that typically develops among older adults.

The agent has demonstrated “encouraging results,” James Caruso, president and CEO of Cellectar Biosciences, said in a company-issued press release.

“The orphan designation from the FDA for [lymphoplasmacytic lymphoma] represents the sixth for CLR 131 and underscores Cellectar’s commitment to develop therapies for rare cancers with limited treatment options and high unmet need,” Caruso said. “We look forward to sharing phase 2 [lymphoplasmacytic lymphoma] clinical data in the near term.”

The FDA previously granted orphan drug designation to CLR 131 for treatment of multiple myeloma, neuroblastoma, rhabdomyosarcoma, Ewing sarcoma and osteosarcoma.

The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.

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

The FDA granted orphan drug designation to CLR 131 for treatment of lymphoplasmacytic 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.

The ongoing phase 2 CLOVER-1 trial is evaluating CLR 131 for treatment of patients with relapsed or refractory B-cell lymphomas, including lymphoplasmacytic lymphoma, a rare form of non-Hodgkin lymphoma that typically develops among older adults.

The agent has demonstrated “encouraging results,” James Caruso, president and CEO of Cellectar Biosciences, said in a company-issued press release.

“The orphan designation from the FDA for [lymphoplasmacytic lymphoma] represents the sixth for CLR 131 and underscores Cellectar’s commitment to develop therapies for rare cancers with limited treatment options and high unmet need,” Caruso said. “We look forward to sharing phase 2 [lymphoplasmacytic lymphoma] clinical data in the near term.”

The FDA previously granted orphan drug designation to CLR 131 for treatment of multiple myeloma, neuroblastoma, rhabdomyosarcoma, Ewing sarcoma and osteosarcoma.

The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.

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