FDA grants fast track designation to tipifarnib for T-cell lymphomas
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The FDA granted fast track designation to tipifarnib for treatment of adults with one of several types of T-cell lymphoma, according to the agent’s manufacturer.
The designation applies to the agent’s use for patients with relapsed or refractory angioimmunoblastic T-cell lymphoma, follicular T-cell lymphoma and nodal peripheral T-cell lymphoma with T follicular helper phenotype.
Tipifarnib (Kura Oncology) is a selective farnesyl transferase inhibitor that has shown durable anticancer activity in certain subsets of patients with solid tumors and hematologic malignancies.
The FDA based the fast track designation on data presented at last year’s ASH Annual Meeting and Exposition that showed tipifarnib exhibited durable activity as monotherapy for relapsed or refractory angioimmunoblastic T-cell lymphoma. Researchers reported an approximately 50% objective response rate among patients who had received a median three prior therapies.
The agent also induced a 70% ORR and 40% complete response rate among patients who had mutations in the killer-cell immunoglobulin-like receptor.
“This important designation from the FDA comes just 2 months after tipifarnib was awarded fast track [designation] for the treatment of patients with HRAS-mutant head and neck squamous cell carcinomas,” Bridget Martell, MA, MD, acting chief medical officer of Kura Oncology, said in a company-issued press release. “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.”