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Cardiff Oncology Announces Expanded Access Program for Onvansertib in KRAS-Mutated Metastatic Colorectal Cancer as Follow-On to Fast Track Designation
-- Initiation of Expanded Access Program follows FDA granting Fast Track Designation of onvansertib for second-line treatment of patients with KRAS-mutation
About this update from Cardiff Oncology, Inc.
[{"type":"text","content":"-- Initiation of Expanded Access Program follows FDA granting Fast Track Designation of onvansertib for second-line treatment of patients with KRAS-mutation mCRC\n -- Expanded Access Program provides pathway for patients to gain access to treatment with onvansertib outside of clinical trials\n\n\nSAN DIEGO, June 9, 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 initiation of its Expanded Access Program (EAP) for its investigational drug onvansertib, in combination with standard-of-care FOLFIRI and bevacizumab, for second-line treatment of patients with KRAS-mutated metastatic colorectal cancer (mCRC).\n\n \n \n \n \n \n \n\n \n\"We are excited to offer expanded access to our investigational drug for patients with KRAS-mutated mCRC who may benefit from treatment with onvansertib, but may not be able to participate in our clinical trial,\" said Dr. Mark Erlander, Chief Executive Officer of Cardiff Oncology. \"The granting of Fast Track Designation coupled with the initiation of our Expanded Access Program underscores the medical need for a new therapeutic option to treat these patients who are facing a devastating prognosis. We are dedicated to advancing the clinical development of onvansertib so that many more patients will have access to treatment in our ongoing trials and through our compassionate use program.\" \nThe Expanded Access Program (or compassionate use) is a program recognized by the FDA as a follow-on to their granting Fast Track Designation to onvansertib. An EAP provides a potential pathway for patients with a serious or life-threatening condition to gain access to an investigational drug for treatment outside of a clinical trial, particularly when no comparable or satisfactory alternative therapy options are available. The Cardiff Oncology EAP is intended for use in combination with FOLFIRI and bevacizumab for the second-line treatment of patients with KRAS-mutated mCRC that have progressed on prior FOLFOX (with or without bevacizumab) therapy.\nRequests for expanded access to onvansertib must be made by a U.S. licensed, treating physician. Physicians can lear...