Quick answers
- What is Tazemetostat used for?
- The FDA-approved label (Tazverik, Epizyme, Inc., April 29, 2026) says: “TAZVERIK is a methyltransferase inhibitor 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 page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tazemetostat have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Tazemetostat?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated March 27, 2026). Ask your pharmacist about alternatives.
- Has Tazemetostat been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Tazemetostat?
- 1 company lists prescription products of Tazemetostat in the FDA NDC Directory, including Epizyme, Inc..
What Tazemetostat is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
TAZVERIK is a methyltransferase inhibitor 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. …
— FDA label: Tazverik, Epizyme, Inc., effective April 29, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Tazverik |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Epizyme, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA211723 TAZVERIK | Epizyme Inc | January 23, 2020 | 2, latest August 13, 2024 2024: Labeling · 2023: Labeling |
Shortage status
To be discontinued · updated March 27, 2026 · first posted March 27, 2026
| Product | Tazverik, Tablet, 200 mg (NDC 72607-100-00) |
|---|---|
| Company | Epizyme, Inc. (An Ipsen Company) |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2274384, 2274390 |
|---|---|
| SPL set ID of the quoted label | 7db07b5f-4e22-467c-9c0a-f830b08dbb1d |
| FDA labels (SPL) | 1 |
| FDA applications | NDA211723 |
| Active ingredients (FDA) | TAZEMETOSTAT |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tazverik, Epizyme, Inc., effective April 29, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →