- The US Food and Drug Administration (FDA) has granted accelerated approval to tazemetostat (Tazverik) for the treatment of adults with relapsed or refractory follicular lymphoma (R/R FL) harboring an EZH2 mutation.
- Patients must have received at least 2 prior systemic therapies or have no other satisfactory alternative treatment options.
- The recommended dose is 800 mg orally twice daily with or without food.
- FDA has also approved the cobas EZH2 Mutation Test, a companion diagnostic test for tazemetostat.
Why this matters
- There is no clear standard of care in the R/R FL population, as not all patients are likely to benefit from currently available therapies.
- The approval was based on an open-label, single-arm, phase 2 trial.
- Patients with disease progression after treatment with at least 2 prior systemic regimens were divided into 2 groups: 1 with EZH2-activating mutations (n=45) and the other with wild-type EZH2 (n=54).
- All patients received tazemetostat 800 mg orally twice a day.
- EZH2-activating mutation vs wild-type EZH2 group:
- Overall response rate: 69% vs 34%.
- Complete response: 12% vs 4%.
- Partial response: 57% vs 30%.
- Median duration of response: 10.9 months and ongoing vs 13 months.
- The most common adverse events associated with tazemetostat were fatigue, upper respiratory tract infection, musculoskeletal pain, nausea, and abdominal pain.
- 30% of patients experienced serious adverse reactions.
For Prescribing Information, click here.