Indications of Tazemetostat

1 Epithelioid Sarcoma

Tazemetostat is indicated 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.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

2 Relapsed or Refractory Follicular Lymphoma

• Tazemetostat is indicated for the treatment of adult patients with relapsed or refractory (R/R) follicular  lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and  who have received at least 2 prior systemic therapies.

• Tazemetostat is indicated for the treatment of adult patients with R/R FL who have no satisfactory alternative  treatment options.

These indications are approved under accelerated approval based on overall response rate and duration of  response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

from FDA，2024.08