Tazverik (tazemetostat) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

Citation

Epizyme, Inc. Tazverik (tazemetostat) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211723s004lbl.pdf. Revised November 2023. Accessed October 30, 2024.

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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
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). 7

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) EZH2 p.Y646N Follicular Lymphoma Tazemetostat
Sensitivity (+) EZH2 p.Y646F Follicular Lymphoma Tazemetostat
Sensitivity (+) EZH2 p.Y646H Follicular Lymphoma Tazemetostat
Sensitivity (+) EZH2 p.Y646S Follicular Lymphoma Tazemetostat
Sensitivity (+) EZH2 p.Y646C Follicular Lymphoma Tazemetostat
Sensitivity (+) EZH2 p.A862G Follicular Lymphoma Tazemetostat
Sensitivity (+) EZH2 p.A692V Follicular Lymphoma Tazemetostat