The Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Tazverik® (tazemetostat; Epizyme) for the treatment of patients with relapsed or refractory follicular lymphoma (FL) who have received at least 2 prior lines of systemic therapy.
Tazemetostat is an oral, selective inhibitor of the methyltransferase, EZH2. The sNDA is supported by data from the open-label, multicenter, phase 2 study (NCT01897571) that assessed the efficacy and safety of tazemetostat 800mg twice daily as monotherapy for adult patients with follicular lymphoma with either EZH2 activating mutation (n=45) or wild-type EZH2 (n=54), who have received at least 2 prior lines of systemic therapy. The primary end point was objective response rate; secondary end points included progression-free survival and safety.
Findings from the study showed that treatment with tazemetostat resulted in meaningful clinical activity as assessed by an Independent Review Committee (IRC) as of August 9, 2019:
- Objective response rate (ORR) of 69% for patients with an EZH2 mutation and 35% for patients with wild-type EZH2
- Median duration of response of 11 months for patients with an EZH2 mutation and 13 months for patients with wild-type EZH2
- Median progression-free survival of 14 months for patients with an EZH2 mutation and 11 months for patients with wild-type EZH2
- Overall survival has not yet been reached for either follicular lymphoma patient population.
With regard to safety, the most common treatment-emergent adverse events of grade 3 or higher included thrombocytopenia (3%), anemia (2%), asthenia (1%) and fatigue (1%).
A Prescription Drug User Fee Act (PDUFA) target date of June 18, 2020 has been set for this application.
In addition, the Company is investigating the combination of Tazverik with “R2” (Revlimid® plus Rituxan®), an approved chemo-free treatment regimen, in a phase 3 study for follicular lymphoma patients in the second-line or later treatment setting.
In January 2020, the FDA granted accelerated approval to Tazverik (tazemetostat) for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
For more information visit epizyme.com.