FDA Grants Orphan Drug Status to Curis’ Blood Cancer Candidate

The US Food and Drug Administration (FDA) has granted Orphan Drug designation to Curis’ blood cancer candidate.

The cancer biotech company announced today that the agency granted Orphan Drug designation to its lead proprietary drug candidate, CUDC-907, for the treatment of Diffuse Large B-Cell Lymphoma (DLBCL). The agency grants orphan drug status to drugs and biologics intended for use in rare diseases or disorders, defined as those affecting fewer than 200,000 people in the US. Among benefits included with orphan drug designation is a seven-year period of market exclusivity if approved by the agency.

CUDC-907 is an oral, dual inhibitor of histone deacetylase (HDAC) and phosphoinositide 3-kinase (PI3K) enzymes. The drug is currently being tested in early-stage studies in patients with relapsed or refractory lymphomas or multiple myeloma, as well as in patients with advanced/relapsed solid tumors, including hormone receptor positive (HR+)/HER2-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,” said Ali Fattaey, PhD, President and Chief Executive Officer of Curis. “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.”

DLBCL is an aggressive form and the largest subtype of non-hodgkin lymphoma (NHL), a clinically and pathologically heterogeneous group of lymphoproliferative malignancies that are predominantly of B-cell origin and have diverse patterns of behavior and responses to treatment. DLBCL accounts for approximately 30-35 percent of all NHL diagnoses. The American Cancer Society (ACS) estimates that this year there will be 71,850 new cases of NHL in the US and 19,790 people will die of the disease.

Source: Curis, Inc.

Last updated: 4/6/15; 2:25pm EST

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