NEW YORK – The US Food and Drug Administration granted accelerated approval on Thursday to Epizyme's tazemetostat (Tazverik) for relapsed or refractory follicular lymphoma patients with an EZH2 mutation as detected by an FDA approved test.
The FDA also approved the Cobas EZH2 Mutation Test by Roche as a companion diagnostic for tazemetostat.
The approval was based on data from two single-arm cohorts of a study involving patients with pretreated follicular lymphoma. In the study, EZH2 mutations were identified prospectively in patients' tumor samples using the Cobas EZH2 Mutation test.
In 42 patients with EZH2 mutated follicular lymphoma, the overall response rate to tazemetostat was 69 percent, with 12 percent of patients having a complete response and 57 percent of patients having a partial response. The median duration of response in this cohort was 10.9 months.
In 53 follicular lymphoma patients who did not harbor an EZH2 mutation, the overall response rate was 34 percent with 4 percent of patients having a complete response and 30 percent of patients having a partial response. The median duration of response in this cohort was 13 months.
The most common adverse reactions to treatment were fatigue, upper respiratory tract infections, musculoskeletal pain, nausea, and abdominal pain. Eight patients discontinued treatment due to adverse events.
"There remains no clear standard of care in the relapsed and/or refractory [follicular lymphoma] population as not all patients benefit from today’s available therapies. Based on this label, physicians will have the ability to use their clinical discretion to prescribe Tazverik for their relapsed or refractory patients regardless of EZH2 mutational status and without regard to a specific line of treatment where other options are not satisfactory," Epizyme CMO Shefali Agarwal said in a statement.
Epizyme will conduct a global, randomized confirmatory trial to evaluate the combination of tazemetostat plus rituximab for follicular lymphoma patients in the second-line or later treatment setting. The trial will enroll approximately 500 patients based on EZH2 mutation status.