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Cardiff Oncology Announces Fast Track Designation Granted by the FDA to Onvansertib for Second-Line Treatment of KRAS-Mutated Colorectal Cancer
- The U.S. Food and Drug Administration reviewed the Company's request for Fast Track designation and concluded that investigation of onvansertib, in
About this update from Cardiff Oncology, Inc.
[{"type":"text","content":"- The U.S. Food and Drug Administration reviewed the Company's request for Fast Track designation and concluded that investigation of onvansertib, in combination with FOLFIRI/bevacizumab, for second-line treatment of patients with KRAS-mutated metastatic colorectal cancer meets the criteria for a Fast Track development program\n - Fast Track designation for onvansertib in KRAS-mutated metastatic colorectal cancer underscores the urgent need for new treatment options for these patients\n\n\nSAN DIEGO, May 28, 2020 /PRNewswire/ -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology therapeutics company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, Zytiga®-resistant prostate cancer and leukemia, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to onvansertib, its oral and highly-selective Polo-like Kinase 1 (PLK1) inhibitor, for the second-line treatment of patients with KRAS-mutated metastatic colorectal cancer (mCRC).\n\n \n \n \n \n \n \n\n \n\"We are very pleased with the FDA's decision to grant Fast Track designation for development of onvansertib to treat patients with KRAS-mutated mCRC,\" said Dr. Mark Erlander, Chief Executive Officer of Cardiff Oncology. \"This designation is a significant validation of not only our onvansertib clinical program, which is now eligible for priority review and accelerated approval, but it also signifies recognition of the medical need for new effective treatment options. The efficacy of current second-line therapy in terms of response and survival prolongation remains very limited, particularly in the KRAS-mutated population, and we are confident that onvansertib, in combination with FOLFIRI/bevacizumab, represents a promising new treatment option.\"\nFast Track is a designation granted by the FDA that is intended to facilitate development and expedite review of drugs to address an unmet medical need in the treatment of a serious life-threatening condition, and for which nonclinical or clinical data has demonstrated the potential of the drug to address this medical need.\nA drug that receives Fast track Designation is eligible for some, or all, of the following:\nEligibility for accelerated approval and priority review, if relevant criteria are me...