FDA approves Tazverik for follicular lymphoma subset
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The FDA granted accelerated approval to tazemetostat for the treatment of adults with relapsed or refractory follicular lymphoma.
This approval of tazemetostat (Tazverik, Epizyme), an EZH2 inhibitor, applies to patients with an EZH2 mutation who have received at least two prior therapies, and for adults with relapsed/refractory follicular lymphoma who have no satisfactory alternative treatment options.
The FDA also approved the cobas EZH2 Mutation Test (Roche Molecular Systems Inc.) as a companion diagnostic for tazemetostat to detect the EZH2 mutation.
Data from two cohorts of the open-label, single-arm, multicenter phase 2 Study E7438-G000-101 supported this approval. These included a cohort of 45 patients (median age, 62 years; 42% men) with an EZH2 activating mutation and a cohort of 54 patients (median age, 61 years; 63% men) with wild-type EZH2.
All patients received 800 mg oral tazemetostat twice daily until disease progression or unacceptable toxicity.
Among those with the EZH2 mutation who had received at least two prior therapies (n = 42), researchers reported a 69% (95% CI, 53-82) overall response rate, including a 12% complete response rate and 57% partial response rate. Median duration of response in this cohort was 10.9 months (95% CI, 7.2-not estimable).
Researchers reported a 34% (95% CI, 22-48) ORR for patients in the EZH2 wild-type cohort previously treated with two therapies (n = 53), with a 4% complete response rate and 30% partial response rate. Median duration of response for these patients was 13 months (95% CI, 5.6-not estimable).
Fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain were the most common adverse events associated with tazemetostat. Thirty percent of patients experienced serious adverse events, most of which were from infection.
The prescribing information for tazemetostat includes a warning and precaution regarding secondary malignancies, which served as the most common reason for treatment discontinuation in the trial, occurring in 2% of patients.
“Follicular lymphoma remains an incurable disease, and even with the availability of new drugs in recent years, there have remained important unmet needs in the treatment of follicular lymphoma,” John P. Leonard, MD, the Richard T. Silver distinguished professor of hematology and medical oncology at Weill Cornell Medicine, oncologist at NewYork-Presbyterian/Weill Cornell Medical Center, and an investigator in the phase 1b/3 confirmatory trial for tazemetostat for follicular lymphoma, said in a company-issued press release. “The durable responses observed with this drug are notable in the context of the safety profile and route of oral, at-home administration, and will offer an important new option for physicians as we care for patients with relapsed/refractory follicular lymphoma.”
This application previously received FDA priority review and fast track designation.
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