Yes, Tazemetostat, marketed under the brand name Tazverik, is FDA approved. The U.S. Food and Drug Administration (FDA) approved Tazemetostat on January 23, 2020, for the treatment of specific types of advanced cancers, specifically epithelioid sarcoma and follicular lymphoma.
Tazemetostat is an oral medication used to treat advanced epithelioid sarcoma, a rare and slow-growing type of soft tissue cancer. It is prescribed for cases where the cancer has metastasized or cannot be removed surgically. Additionally, Tazemetostat is used to treat follicular lymphoma, a type of non-Hodgkin lymphoma, particularly in patients with an EZH2 mutation or those who have not responded to at least two prior systemic therapies.
The FDA granted accelerated approval to Tazemetostat based on clinical study results that showed a significant number of patients responding to the treatment. However, further studies are needed to confirm the clinical benefits of Tazemetostat.
Tazemetostat is administered orally in tablet form. The typical dosage for adults and children aged 16 and older is:
Tazemetostat can cause a range of side effects, some of which may be severe. Common side effects include:
Serious side effects may include unusual tiredness, bone pain, and low blood cell counts, which could manifest as fever, chills, mouth sores, easy bruising, unusual bleeding, pale skin, or shortness of breath. Patients experiencing these symptoms should seek immediate medical attention.
Tazemetostat may increase the risk of developing bone marrow disorders or other cancers, such as leukemia or lymphoma. Patients are advised to have a negative pregnancy test before starting treatment and to use effective nonhormonal birth control during and for six months after treatment, as the drug can harm an unborn baby. Hormonal contraceptives may be less effective when used alongside Tazemetostat, so barrier methods are recommended.
Patients should follow their healthcare provider's instructions carefully, taking Tazemetostat tablets whole without crushing, chewing, or breaking them. The medication can be taken with or without food, but patients should avoid grapefruit products and St. John's wort, as these can interfere with the drug's effectiveness.
Tazemetostat (Tazverik) represents an important advancement in the treatment of certain advanced cancers, particularly epithelioid sarcoma and follicular lymphoma. Its FDA approval marks a significant step forward, offering hope to patients with these challenging conditions. As with any medication, it is crucial for patients to adhere to their healthcare provider's guidance and report any side effects promptly to ensure the best possible outcomes.
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