Regulatory approval

Published by the Food and Drug Administration. Approved

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).

This is written in the approval document.

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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Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations Biomarkers Cancer types Therapies
FDA (1) EZH2 p.Y646N Follicular Lymphoma Tazemetostat
FDA (1) EZH2 p.Y646F Follicular Lymphoma Tazemetostat
FDA (1) EZH2 p.Y646H Follicular Lymphoma Tazemetostat
FDA (1) EZH2 p.Y646S Follicular Lymphoma Tazemetostat
FDA (1) EZH2 p.Y646C Follicular Lymphoma Tazemetostat
FDA (1) EZH2 p.A682G Follicular Lymphoma Tazemetostat
FDA (1) EZH2 p.A692V Follicular Lymphoma Tazemetostat