KURA - Kura climbs on FDA breakthrough therapy status for tipifarnib in head and neck carcinoma

Kura Oncology (KURA) has added ~14.1% in the premarket after announcing that it has received the breakthrough therapy designation from the FDA for tipifarnib in the treatment of recurrent or metastatic HRAS mutant head and neck squamous cell carcinoma (“HNSCC”).The designation, based on data from RUN-HN, a Phase 2 clinical trial evaluating tipifarnib, is targeted at recurrent or metastatic HRAS mutant HNSCC with variant allele frequency ? 20% after disease progression on platinum-based chemotherapy.The designation will provide Kura the eligibility for priority review, rolling submission of portions of the application and FDA’s guidance for the company to help determine the most efficient route to approval.

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Kura climbs on FDA breakthrough therapy status for tipifarnib in head and neck carcinoma