Dr. Leonard on the FDA Approval of Tazemetostat in Follicular Lymphoma

John P. Leonard, MD, associate dean for clinical research and Richard T. Silver Distinguished Professor of Hematology and Medical Oncology, Meyer Cancer Center, Weill Cornell Medicine and New York Presbyterian Hospital, discusses the FDA approval of tazemetostat in follicular lymphoma.

On June 18, 2020, the FDA granted an accelerated approval to tazemetostat for the treatment of patients with relapsed/refractory follicular lymphoma whose tumors are EZH2 positive as detected by an FDA-approved test and who have received at least 2 prior systemic therapies, as well as those with relapsed/refractory disease who have no other available satisfactory treatment options.

The approval was based predominantly on updated results from an ongoing phase 2 trial, which showed that the first-in-class EZH2 inhibitor led to an objective response rate (ORR) of 69% for patients with EZH2-mutant disease and a 35% ORR for those with wild-type EZH2 disease. The complete response and partial response rates were 13% and 56% in those with EZH2 mutations and 4% and 31% for patients with wild-type EZH2, respectively.

Follicular lymphoma is typically an incurable disease, and one in which patients will see a number of treatments over the course of their lifespan. However, novel therapies are needed for patients who progress through chemotherapy and other available options, says Leonard. The approval provides another agent for this subset of patients who would have otherwise not had good options, concludes Leonard.