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FDA grants breakthrough therapy designation to tipifarnib for HNSCC

Posted on February 24, 2021

The U.S. Food and Drug Administration has granted breakthrough therapy designation to tipifarnib (Kura Oncology, Inc) for the treatment of patients with recurrent or metastatic HRAS mutant head and neck squamous cell carcinoma (HNSCC) with variant allele frequency ≥ 20% after disease progression on platinum-based chemotherapy, according to a press release.

This designation was based on data from a Phase 2 clinical trial evaluating tipifarnib in patients with recurrent or metastatic HRAS mutant HNSCC. Among the 18 evaluable patients, there was an objective response rate of 50%, median progression-free survival of 5.9 months, and a median overall survival of 15.4 months.

Approximately 4-8% of patients with HNSCC have the HRAS biomarker.

“We are very pleased that the FDA has awarded Breakthrough Therapy Designation to tipifarnib, and we appreciate the agency’s affirmation of its potential to treat this devastating disease,” said Troy Wilson, PhD, JD, President and Chief Executive Officer of Kura Oncology, in the press release. “We remain focused on conducting our AIM-HN registration-directed trial and look forward to working closely with the FDA to bring this therapy to patients as soon as possible.”

Read the full press release here.

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