Benzinga | Feb 24, 2021 09:12AM EST

Kura Oncology Receives FDA Breakthrough Therapy Tag For Tipifarnib In Head & Neck Cancer

* 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.