Tazemetostat for the treatment of epithelioid sarcoma was approved by FDA

Tazemetostat has been approved by FDA (US Food and Drug Administration) for the treatment of epithelioid sarcoma as a first-line drug.

Epithelioid sarcoma refers to a rare subtype of soft tissue sarcoma and it can develop in any part of the body, but more often on the extremities. Most often it affects young people. This type has the highest risk of metastasis to the lymph nodes or lungs.

Tazemetostat is an EZH2 methyltransferase inhibitor and it is used to treat metastatic or advanced forms of cancer (grade 3 and 4). This is the first immunotherapy drug to treat epithelioid sarcoma with unique action mechanism. Previous treatment regimens included only surgical treatment, chemotherapy and radiotherapy, which show low effectiveness in the advanced cases.

Tazemetostat has been approved by the FDA accelerated program. Open clinical studies of immunotherapy for epithelioid sarcoma were conducted in 62 patients. They received 800 mg of the drug twice a day. The overall response rate was 15%.

Side effects of treatment may include:

• pain
• fatigue
• nausea
• poor appetite
• vomiting
• constipation.

In some cases, treatment with Tazemostat may increase the risk of secondary malignant tumors.

When this data was discussed by Advisory Committee at FDA, committee members voted unanimously that the treatment benefits outweigh the potential risks. Approving of a new immunotherapy with Tazemetostat gives great promise for patients with epithelioid sarcoma, especially young people.

Source: emed, FDA

Since many studies are being conducted by the United States together with Israel, the immunotherapy drug may already be available in Israel and prescribed by leading oncologists in our country.