FDA Approves First Treatment Specifically for a Rare Soft Tissue Cancer

Epizyme’s Tazverik (tazemetostat) earned accelerated approval from the FDA to treat patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.

Epithelioid sarcoma is a rare sub-type of soft tissue sarcoma that often occurs in young adults. Tazverik is now the first treatment option specifically for patients with epithelioid sarcoma.

The approval was based on the results of a clinical trial of 62 patients with metastatic or locally advanced epithelioid sarcoma receiving 800 mg of Tazverik twice a day until the disease progressed or the patient reached an unacceptable level of toxicity. The overall response rate was 15 percent, with 1.6 percent of patients having a complete response and 13 percent having a partial response.

The FDA’s Oncologic Drugs Advisory Committee voted unanimously in favor of the indication.