Epizyme announced that the US Food and Drug Administration (FDA) had approved Tazverik (tazemetostat) through the accelerated approval and priority review for two different Follicular lymphomas (FL) indications.
In adult patients with relapsed/refractory FL whose tumors are positive for an EZH2 mutation and have received at least two prior systemic therapies
In adult patients with relapsed/refractory FL with no satisfactory alternative treatment options
The US FDA approval was based on an open-label, single-arm, multi-center Phase II clinical trial (Study E7438-G000-101, NCT01897571) in FL patients who have received at least two prior systemic therapy.
The primary endpoint in patients with an EZH2 activating mutation:
Overall response rate (ORR) achieved in 69% of patients to Tazverik, including 12% achieving a complete response.
The median duration of response was 10.9 months.
The primary endpoint in patients in with wild-type EZH2:
Overall response rate (ORR) was 34%, including 4% who achieved a complete response and 30% achieving a partial response
The median duration of response was 13 months.
Serious adverse events such as general physical health deterioration, abdominal pain, pneumonia, sepsis, and anemia observed in ≥2% of patients. Eight patients discontinued the study.
Tazverik (tazemetostat) is a methyltransferase inhibitor. FL is the second indication to be approved through accelerated approval in January 2020 Tazverik was approved for the treatment of adult and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.