The FDA recently granted fast track designation to abexinostat, a novel, fourth-line monotherapy for relapsed or refractory follicular lymphoma, according to a press release from the manufacturer.
The designation was granted while abexinostat is currently in Phase II trials in the United States and Europe as a single agent for the treatment of follicular lymphoma.
Previous phase two trial data, published in Haematoligica, studied 100 patients with 100 patients with B-cell malignancies and T-cell lymphomas. In that study, the highest overall response rate was in patients with follicular lymphoma, at 56%.
However, in that study, treatment-related adverse events were experienced by the majority of the study cohort, with Grade 3 events in 88% and serious adverse events in 73%. Adverse events included thrombocytopenia, neutropenia, and anemia.
“This phase II study showed that abexinostat is clinically active in patients with relapsed/refractory NHL, especially in patients with FL, T-CL, and DLBCL, who exhibited high response rates and durable tumor control,” Vincent Ribrag, MD, of the Institut de Cancérologie Gustave Roussy, Villejuif, France, and colleagues wrote in that study. “Abexinostat showed good tolerability during prolonged drug administration; however, using a less dose-intense schedule may mitigate the hematologic toxicity.”
The FDA previously granted fast-track designation to abexinostat in combination with pazopanib for treatment of RCC.