With new data supporting use of its farnesyl transferase inhibitor tipifarnib in second-line, HRAS-mutant head and neck squamous cell carcinoma, Kura Oncology Inc. is hoping a Phase II trial in that setting will be enough to seek US Food and Drug Administration approval. The San Diego firm presented data from a small cohort of a larger Phase II trial of tipifarnib in HRAS-mutant cancers on 29 May during a virtual session of the American Society of Clinical Oncology meeting.
CEO Troy Wilson explained that Kura was able to optimize tipifarnib by using genomic screening to find the head-and-neck cancer patients who were most likely to benefit from the drug. Originally discovered and developed by Johnson & Johnson, the drug – known then as Zarnestra – received a “not approvable” letter for the treatment of acute myeloid leukemia (AML) from the FDA in 2005 and the pharma shelved it soon after. (Also see "J&J Zarnestra Receives “Not Approvable” Letter From FDA" - Pink Sheet, 30 June, 2005
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