FDA grants orphan drug status to Cardiff Oncology's onvansertib for CMML

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Go back to FDA grants orphan drug status to Cardiff Oncology's onvansertib for CMML

Cardiff Oncology Receives FDA Orphan Drug Designation for Onvansertib in Chronic Myelomonocytic Leukemia

October 21, 2026 4:05 PM EDT

SAN DIEGO, Oct. 21, 2026 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to onvansertib for the treatment of patients with chronic myelomonocytic leukemia (CMML).

CMML remains a difficult-to-treat hematologic malignancy with limited treatment options for patients, and 40-50% of myeloproliferative CMML1 patients harbor RAS-pathway mutations, which are associated with more aggressive disease, said Mani Mohindru, PhD, President and Chief Executive Officer of Cardiff Oncology. Receiving Orphan Drug... More