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NEW YORK – Kura Oncology this week received breakthrough therapy designation from the US Food and Drug Administration for tipifarnib in HRAS-mutated head and neck cancer. The designation was based on data from the Phase II RUN-HN trial studying tipifarnib in HRAS-mutant head and neck cancer patients with recurrent or metastatic disease. Among 18 evaluable patients taking tipifarnib, the objective response rate was 50 percent, the median progression-free survival was 5.9 months, and the median overall survival was 15.4 months. Kura licensed tipifarnib from Janssen in 2015.

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