Regulatory approval
Published by the Food and Drug Administration.
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 is written in the approval document as:
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).
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.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| 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 |