Tazverik Approved for Epithelioid Sarcoma

On January 23, 2020, the FDA approved tazemetostat (Tazverik; Epizyme), a methyltransferase inhibitor, for the treatment of adults and pediatric patients aged ≥16 years with metastatic or locally advanced epithelioid sarcoma who are not eligible for complete resection. The FDA granted tazemetostat accelerated approval and designated it as an orphan drug.

“Until today, there were no treatment options specifically for patients with epithelioid sarcoma. The approval of tazemetostat provides a treatment option that specifically targets this disease,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence.

The approval of tazemetostat was based on results of the open-label, single-arm cohort (Cohort 5) of a multicenter study in patients with histologically confirmed, metastatic, or locally advanced epithelioid sarcoma. Patients were required to have INI1 protein loss, detected using local tests, and an Eastern Cooperative Oncology Group performance status of 0 to 2.

Patients received tazemetostat 800 mg orally twice daily until disease progression or unacceptable toxicity. Tumor response assessments were performed every 8 weeks. The major efficacy outcome measures in the trial were confirmed overall response rate (ORR) according to Response Evaluation Criteria in Solid Tumors v1.1 as assessed by blinded independent central review and duration of response.

Of the 62 patients treated in Cohort 5, the ORR was 15%, with 1.6% achieving a complete response, and 13% achieving a partial response. Among the 9 responders, 6 (67%) had a duration of response that lasted ≥6 months.

The most common (≥20%) adverse reactions assoctiated with tazemetostat were pain, fatigue, nausea, decreased appetite, vomiting, and constipation.

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