The US Food and Drug Administration approved Epizyme’s Tazverik (tazemetostat) for patients with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. The drug is approved in adults and pediatric patients aged 16 years and older.
“Until today, there were no treatment options specifically for patients with epithelioid sarcoma. The approval of Tazverik provides a treatment option that specifically targets this disease,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence.
The approval is based in the Phase 2 trial, which included 62 patients with a median age of 34 years. Patients were administered with 800 mg of Tazverik. Overall response rate (ORR) was the primary endpoint; 1.6% of patients achieved a complete response and 13% of patients achieved a partial response at 14 months.
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Tazverik acts by inhibiting EZH2 methyltransferase, the enzyme involved in allowing the growth of cancer. Earlier, Tazverik has received accelerated approval and orphan designation from the FDA.
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About epithelioid sarcoma
The epithelioid sarcoma is a soft-tissue sarcoma that develops under the skin, though it can develop in other parts of the body. Surgical removal is considered as one of the treatment options. Chemotherapy and radiation are other treatment options. This condition is life-threatening to the patient.