Anti-ROR1 monoclonal antibody granted orphan drug designation for treatment of MCL, CLL
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to cirmtuzumab for the treatment of mantle cell lymphoma (MCL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL), according to a press release from Oncternal Therapeutics, Inc.
The investigational anti-ROR1 monoclonal antibody is currently being evaluated in clinical trials in patients with MCL, CLL, and HER2-negative breast cancer.
“We are pleased to receive orphan drug designations for cirmtuzumab, our potentially first-in-class investigational ROR1 antibody,” said James Breitmeyer, MD, PhD, Oncternal’s President and CEO, in the press release. “We are excited about cirmtuzumab’s potential for the treatment of patients with ROR1-expressing cancers, including MCL, CLL, HER2-negative breast cancer and other solid tumors, and look forward to further advancing its development to benefit patients with significant unmet medical needs.”
Read the full press release here.