Tazverik Receives Accelerated Approval for Follicular Lymphoma

The United States Food and Drug Administration (US FDA) has approved Tazverik for use in relapsed or refractory (R/R) follicular lymphoma. Tazverik (tazemetostat) is for adults with a mutation in a specific gene called an EZH2 mutation. These individuals must also have tried at least 2 other treatment options in the past.

People with R/R follicular lymphoma who do not have this mutation can also take Tazverik if they have no other treatment options available. In addition, the FDA approved a specific genetic test that your doctor can use to determine if you have the EZH2 mutation or not.

Tazverik is also approved for the treatment of another type of cancer called epithelioid sarcoma.

How does Tazverik work?

Tazverik belongs to a class of drugs called methyltransferase inhibitors. It specifically blocks a protein called EZH2. This type of drug, and the protein it blocks, are involved in tumor growth and spread. EZH2 plays a role in turning on and off certain genes, allowing cancer cells to grow and divide. By blocking this protein, Tazverik may block cancer genes and slow progression.

Tazverik in clinical trials

Tazverik was tested in a clinical trial with participants who had follicular lymphoma. These participants had lymphoma that had continued to spread after trying at least 2 other treatment options. Some people participating had lymphoma with the normal version of the EZH2 gene, and others had a mutated version of the gene.

Overall, almost 70 percent of people with the mutated EZH2 gene responded to the drug. About 12 percent had a complete response and almost 60 percent had at least a partial response to the new drug. Those without the mutated EZH2 gene had about a 34 percent response rate. The median length of response was almost 11 months for those with the mutated gene and 13 months for those without the mutation. These results show that Tazverik may be helpful in slowing the progression of follicular lymphoma in both people with the EZH2 mutation and without.

What are the side effects of Tazverik?

The side effects of Tazverik can vary based on what the drug is used for. For people taking Tazverik for follicular lymphoma, the most common side effects include:

• Fatigue
• Joint or muscle pain
• Nausea or abdominal pain
• Upper respiratory infections

This is not a complete list of all possible side effects of Tazverik. Ask your doctor for more information.

Things to know about Tazverik

As with any other drug, there are several rare but serious side effects that can happen while taking Tazverik. Tazverik may increase a person’s risk of developing a second cancer, especially certain blood cancers. Some of these secondary cancers include T-cell lymphoblastic leukemia, myelodysplastic syndrome, and acute myeloid leukemia. Talk with your doctor about your risk of developing a second cancer while taking the drug.

Some drugs, vitamins, and supplements may impact the way Tazverik works. Tell your doctor about any other drugs you are taking, including over-the-counter options.

Tazverik may harm an unborn baby. Because of this, effective birth control methods are needed for females and males taking the drug. Birth control may be needed for some time after stopping the drug as well. Your doctor can help you and your partner understand what is needed if one of you could become pregnant. Tazverik may also pass through breast milk, so women taking Tazverik are advised not to breastfeed.

Read the prescribing information to learn more about Tazverik.¹