The FDA granted fast track designation to Kura Oncology’s (NASDAQ:KURA) tipifarnib for the treatment of adult patients with relapsed or refractory angioimmunoblastic T-cell lymphoma, follicular T-cell lymphoma and nodal peripheral T-cell lymphoma with T-follicular helper phenotype.
In December 2019, Kura reported updated Phase 2 data demonstrating an objective response rate of approximately 50% in a heavily pre-treated patient population, with a median of three prior regimens. Patients who carried mutations in the killer-cell immunoglobulin-like receptor had an objective response rate of 70% and a complete response rate of 40%.
“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,” Dr. Bridget Martell, Kura’s acting CMO, said in a statement.
“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 T-follicular helper phenotype, including angioimmunoblastic T-cell lymphoma,” she added.
