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

by Vandana Singh, Benzinga Editor

February 24, 2021 9:12 AM | 1 min read | Make a Comment

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.

Posted In: Biotech News FDA General neck cancer

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