FDA grants orphan drug designation to CUDC-907 for DLBCL

The FDA today granted orphan drug designation to CUDC-907 for the treatment of diffuse large B-cell lymphoma, according to a press release from the drug’s manufacturer.

CUDC-907 (Curis) — an oral, dual inhibitor of histone deacetylase and phosphoinositide 3-kinase enzymes — is currently being evaluated in a phase 1 clinical study composed of patients with relapsed or refractory lymphomas or multiple myeloma. The drug is also being evaluated in a phase 1 study of patients with advanced/relapsed solid tumors, including hormone receptor-positive, HER-2–negative breast cancer or midline carcinoma with certain NUT gene rearrangements.

"We are pleased to receive Orphan Drug Designation for CUDC-907 in DLBCL, which represents an area of significant unmet need, especially in the relapsed/refractory setting," Ali Fattaey, PhD, president and chief executive officer of Curis, said in a press release. "We are continuing to treat DLBCL patients with CUDC-907 in the expansion stage of our phase 1 study and anticipate initiating a phase 2 trial in this indication in the second half of the year."

The FDA’s 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.