WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration has granted accelerated approval to Tazverik for the treatment of adults and pediatric 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.
'Epithelioid sarcoma accounts for less than one percent of all soft tissue sarcomas,' said Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA's Center for Drug Evaluation and Research. '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. When we brought Tazverik's application to the Oncologic Drugs Advisory Committee last month, the committee voted unanimously that the benefits of the drug outweighed the risks.'
Tazverik blocks activity of the EZH2 methyltransferase, which may help keep the cancer cells from growing. Most cases of epithelioid sarcoma begin in the soft tissue under the skin of an extremity, though it can start in other areas of the body.
Tazverik's approval was based on the results of a clinical trial enrolling 62 patients with metastatic or locally advanced epithelioid sarcoma.
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