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FDA Approves Tazemetostat for Relapsed/Refractory FL
On June 18, 2020, the FDA granted accelerated approval to tazemetostat (Tazverik; Epizyme) for the treatment of adult patients with confirmed EZH2-positive relapsed/refractory follicular lymphoma (FL) who have received at least 2 prior systemic therapies, and adult patients with relapsed/refractory FL who have no satisfactory alternative therapy options.
Additionally, the FDA approved the cobas EZH2 Mutation Test (Roche Molecular Systems) as a companion diagnostic for the drug.
This approval was based on efficacy results from 2 open-label, single-arm cohorts of a multicenter trial. The trial enrolled patients with histologically confirmed FL who had received at least 2 prior systemic therapies.
The cobas EZH2 Mutation Test was used to identify EZH2 mutations in formalin-fixed, paraffin-embedded tumor samples. Patients enrolled on the trial received tazemetostat 800 mg orally twice daily until disease progression or unacceptable toxicity.
The main efficacy measures were overall response rate (ORR) and duration of response (DOR) according to International Working Group Non-Hodgkin Lymphoma criteria, as assessed by an independent review committee.
The ORR in 42 patients with EZH2 mutant FL was 69% (95% CI: 53%, 82%), with 12% complete responses and 57% partial response. Median DOR was 10.9 months (95% CI: 7.2, NE). The ORR in 53 patients with EZH2 wild-type FL was 34% (95% CI: 22%, 48%), with 4% complete responses and 30% partial responses. Median DOR was 13 months (95% CI: 5.6, NE).
The most common (≥20%) adverse events (AEs) included fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain. Serious AEs occurred in 30% of patients, most common being infection. Second primary malignancy was reported in 2% of patients and was the most common reason for treatment discontinuation.—Janelle Bradley
Source: US Food and Drug Administration. FDA granted accelerated approval to tazemetostat for follicular lymphoma. Updated June 18, 2020. https://www.fda.gov/drugs/fda-granted-accelerated-approval-tazemetostat-follicular-lymphoma. Accessed June 18, 2020.
