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Anti-ROR1 monoclonal antibody granted orphan drug designation for treatment of MCL, CLL

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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.

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