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Epizyme gets FDA nod for Tazverik

Levy

Patients with a rare subtype of soft tissue sarcoma now have a treatment option. The Food and Drug Administration has approved drug maker Epizyme's Tazverik (tazemetostat), the first treatment option specifically for patients with epitheliod sarcoma, which often occurs in young adults. 

The drug is indicated to treat metastatic or locally advanced epithelioid sarcoma in adults and children 16 years old and older who are not eligible for complete surgical removal of the sarcoma.

"Epithelioid sarcoma accounts for less than 1% of all soft tissue sarcomas," said Richard Pazdur,  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."

 

 

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