Tazverik (tazemetostat)

What is Tazverik (tazemetostat) for?

Tazverik (tazemetostat) is a medication indicated for the treatment of :

• Adults and pediatric patients aged 16 years and older with advanced or metastasized epithelioid sarcoma (ES).^[1,2]
• Adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) with a EZH2 mutation who have received ≥2 prior systemic therapies.^[3]
• Adult patients with R/R FL who have no satisfactory alternative treatment options.^[3]

How does Tazverik (tazemetostat) work?

Tazverik is a small molecule that acts as an inhibitor of the histone methyltransferase Enhancer of Zeste Homologue 2 (EZH2). Histone methyltransferases are enzymes that can suppress (turn off) the activity of specific genes. EZH2 blocks the expression of tumor suppressor genes in healthy cells. Tumor suppressors can keep the cells from dividing too quickly, repair DNA mistakes, or tell cells when to die.^[1]

ES a rare slow-growing type of cancer affecting soft tissue. In over 90% of ES tumors and in 25% of FL tumors, EZH2 is overactive, allowing cancer cells to grow and divide rapidly.1,4 Tazverik works to inhibit EZH2, with the goal of slowing down tumor growth and killing cancer cells.^[1]

Where has Tazverik (tazemetostat) been approved?

Tazverik (tazemetostat) was approved by:

• The Food and Drug Administration (FDA), USA:
  • January 23, 2020 with regular approval for the treatment of patients with advanced epithelioid sarcoma (ES). Tazverik was also granted Orphan drug designation.^[2]
  • June 18, 2020 with accelerated approval for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation and who have received at least 2 prior systemic therapies, and for adult patients with R/R FL who have no satisfactory alternative treatment options.^[3]
• The Pharmaceuticals and Medical Devices Agency (PMDA), Japan on June 23, 2021 to treat R/R FL.

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Tazverik taken?

The standard dosage is:^[1]

• Adults: 800 mg (4 tablets) taken twice daily
• Pediatric patients aged ≥16 years: 800 mg (4 tablets) taken twice daily

Complete information about Tazverik (tazemetostat) dosage and administration can be found in the official prescribing information listed in our references section.

Note: Please consult with your treating doctor for personalised dosing.

Are there any known adverse reactions or side effects of Tazverik?

Common adverse reactions

The most common adverse reactions (≥20% of patients) listed in the prescribing information include:^[1]

• Pain
• Fatigue
• Nausea
• Decreased appetite
• Vomiting
• Constipation

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include:^[1]

• Secondary malignancies
• T-cell lymphoblastic lymphoma
• Myelodysplastic syndrome
• Acute myeloid leukemia

Use in a specific population

Tazverik (tazemetostat) can cause fetal harm when administered to a pregnant woman; it is advised to avoid pregnancies and breastfeeding.^[1]

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.^[1]

References

1. Full prescribing information [FDA]: Tazverik (tezemetostat) [PDF]
Epizyme Inc., January 2020.

2. FDA news release: FDA approves first treatment option specifically for patients with epithelioid sarcoma, a rare soft tissue cancer
January 2020.

3. FDA granted accelerated approval to tazemetostat for follicular lymphoma
18 June 2020.

4. EZH2 mutations are frequent and represent an early event in follicular lymphoma
Bödör, C. Blood, Oct 31 2013.