- The FDA has designated Breakthrough Therapy status to Kura Oncology Inc's (NASDAQ: KURA) tipifarnib, an orally bioavailable inhibitor of farnesyl transferase for head and neck cancer.
- The status covers recurrent or metastatic HRAS mutant head and neck squamous cell carcinoma (HNSCC) with a variant allele frequency of more than 20% after disease progression on platinum-based chemotherapy.
- The FDA has also granted tipifarnib Fast Track designation for the treatment of HRAS mutant HNSCC.
- A Breakthrough Therapy Designation benefits include the eligibility for priority review and rolling submission of the marketing application.
- Price Action: KURA gained 5.04% at $35 in premarket trading on the last check Wednesday.
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