Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that EZH2 p.Y646S status confers therapeutic sensitivity to Tazemetostat in patients with Follicular Lymphoma.
The U.S. Food and Drug Administration granted accelerated approval to tazemetostat for the treatment of adult patients with relapsed or refractory follicular lymphoma 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. The product label states that this indication is approved under accelerated approval based on overall response rate and duration of response and that continued approval for this indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
This statement is based on a regulatory approval from the Food and Drug Administration:
TAZVERIK is a methyltransferase inhibitor indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma 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. 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).