Cardiff Oncology’s (NASDAQ:CRDF) onvansertib received FDA fast track designation for the second-line treatment of patients with KRAS-mutated metastatic colorectal cancer (mCRC).
The company is currently assessing onvansertib, in combination with FOLFIRI and bevacizumab, in a Phase 1b/2 clinical trial that will enroll up to 44 patients.
“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,” Mark Erlander, Cardiff’s CEO, said in a statement.
“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,” he added.
