The Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) voted unanimously (11 – 0) in favor of approving tazemetostat to treat patients with epithelioid sarcoma.  The FDA is scheduled to make its decision for market approval on or before January 23, 2020.

Epithelioid sarcoma is a rare and aggressive type of soft tissue sarcoma that mostly afflicts young adults. A majority of cases begin in the soft tissue of the extremities (fingers, hand, foot, lower leg) but it can begin in anywhere. In approximately half of the cases, surgery can treat the condition, but recurrence is common, as is its ability to metastasize. The average survival rate for this condition typically ranges from 10 to 16 months in patients with an advanced form of this disease (which may account for about half of the patients).

Tazemetostat is an enhancer of zeste homologue 2 (EZH2) inhibitor. EZH2 is associated with the pathophysiology of epithelioid sarcoma. Data presented to ODAC showed that in a phase II clinical trial, the median overall survival time for patients with advanced epithelioid sarcoma was 19 months, and at 57 weeks (14 months), 57% of patients remained alive. Statistics that far exceed the reported survival rates for current treatment options, usually doxorubicin or pazopanib, with reported overall survival rates of 12.8 months and 12.5 months, respectively.

The most common adverse events with tazemetostat were fatigue (40%), nausea (37%), cancer pain (32%),  vomiting (26%),  decreased appetite (24%), and constipation (21%).

In a news release, Shefali Agarwal, MD, chief medical officer of Epizyme, the developers of the drug said, “We believe the strength of the totality of data, including the observed durable responses and stabilization of disease, safety and tolerability, are distinguishing characteristics of tazemetostat for patients living with this disease. We are thrilled by the panel’s support and look forward to working closely with the Agency as they continue their review of our NDA. I am confident that we have submitted a comprehensive clinical data package for ES to support tazemetostat’s approval.”

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