Cardiff Oncology Receives FDA Orphan Drug Designation for Onvansertib in Chronic Myelomonocytic Leukemia
Key Highlights
- ➤FDA grants Cardiff Oncology (CRDF) Orphan Drug Designation for onvansertib in CMML
- ➤Onvansertib showed preliminary efficacy in approximately 40% of myeloproliferative CMML patients
- ➤Clinical benefits included platelet response, white-cell normalization, and spleen response
- ➤One patient achieved marrow blast reduction from 8% to 2%, facilitating stem-cell transplant
- ➤Onvansertib targets RAS-mutated cancers through PLK1 inhibition
Expert Statements
Mani Mohindru, PhD, President and Chief Executive Officer of Cardiff Oncology
“CMML remains a difficult-to-treat hematologic malignancy with limited treatment options for patients, and 40-50% of myeloproliferative CMML(1) patients harbor RAS-pathway mutations, which are associated with more aggressive disease.”
Mani Mohindru, PhD, President and Chief Executive Officer of Cardiff Oncology
“Receiving Orphan Drug Designation for onvansertib in CMML further validates the therapeutic potential of PLK1 inhibition in cancers with significant unmet need and adds to the growing body of evidence supporting this mechanism across both solid tumors and hematologic malignancies.”
Mani Mohindru, PhD, President and Chief Executive Officer of Cardiff Oncology
“We believe this designation highlights the broader clinical opportunity for onvansertib as a monotherapy as we continue advancing therapies for patients across cancers where new therapeutic approaches are urgently needed.”
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 CMML(1) 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 Designation for onvansertib in CMML further validates the therapeutic potential of PLK1 inhibition in cancers with significant unmet need and adds to the growing body of evidence supporting this mechanism across both solid tumors and hematologic malignancies. We believe this designation highlights the broader clinical opportunity for onvansertib as a monotherapy as we continue advancing therapies for patients across cancers where new therapeutic approaches are urgently needed.”
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