FDA Grants Fast Track Designation to Tipifarnib to Treat Lymphoma

The FDA recently granted the fast track designation to Kura Oncology, Inc.’s leading drug candidate, tipifarnib, to treat adult patients of T-cell lymphomas, according to a news release.

The designation is set for tipifarnib to specifically treat adults with relapsed or refractory angioimmunoblastic T-cell lymphoma (AITL), follicular T-cell lymphoma (FTCL) and nodal peripheral T-cell lymphoma with T follicular helper (TFH) phenotype.

“We believe that this designation reflects tipifarnib’s significant potential in these devastating disease settings, and we are now actively preparing to initiate a second registration-directed trial of tipifarnib in advanced nodal lymphomas of TFH phenotype, including AITL,” said Bridget Martell, MA, MD, acting chief medical officer of Kura Oncology.

Kura Oncology updated some clinical data at the American Society of Hematology (ASH) Annual Meeting, showing an objective response rate of 50% in a pre-treated patient population. Even more, patients who carried mutations in the killer-cell immunoglobulin-like receptor saw enhanced anti-tumor activity, and an objective response rate of 70% and complete response rate of 40%.

Kura Oncology is a clinical-stage biopharmaceutical company that focuses on the “development of precision medicines for the treatment of cancer.” The company’s drug pipeline consists of 3 clinical-stage drug candidates that target cancer signaling pathways. Kura’s leading drug candidate, tipifarnib, is a selective farnesyl transferase inhibitor.

“This important designation from the FDA comes just two months after tipifarnib was awarded Fast Track for the treatment of patients with HRAS mutant head and neck squamous cell carcinomas (HNSCC),” explained Martell.

About 20% of all aggressive non-Hodgkin lymphomas, and 20,000 incidence cases annually, are comprised of peripheral T-cell lymphomas. With a 5-year survival rate of just 30%, it is imperative that a drug with high survival benefit is discovered. Although several drugs have been approved in the relapsed and/or refractory setting, tipifarnib will look to be the first drug to successfully lead to significant survival benefit.

The FDA grants fast track designation to drugs that are “intended for the treatment of serious or life-threatening disease or conditions, which demonstrate the potential to address an unmet medical need.” The designation also grants eligibility opportunity for rolling submission of a New Drug Application.

Reference:

Kura Oncology Receives Fast Track Designation for Tipifarnib in T-Cell Lymphomas [news release]. San Diego, California. Published March 3, 2020. http://ir.kuraoncology.com/news-releases/news-release-details/kura-oncology-receives-fast-track-designation-tipifarnib-t-cell. Accessed March 3, 2020.