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US FDA panel unanimously backs Epizyme's rare cancer drug for approval

A panel of outside advisers to the U.S. Food and Drug Administration voted unanimously to approve Epizyme Inc.'s experimental therapy, tazemetostat, for a type of soft tissue cancer.

During a Dec. 18 meeting, the Oncologic Drugs Advisory Committee backed the drug candidate in an 11-0 vote, saying tazemetostat's benefits outweighed its risks, and surprising some analysts expecting a more modest, but still favorable, outcome.

Tazemetostat is slated for a Jan. 23, 2020, FDA decision date. The FDA is not required to adhere to the advisory committee's recommendation.

According to Leerink analyst Andrew Berens, the panelists believed that the drug was easily administered in an oral formulation and provided clinically meaningful benefit to patients with epithelioid sarcoma, a cancer that forms under the skin of a finger, hand, forearm, lower leg or foot, or other areas of the body.

Panelists also said epithelioid sarcoma is a rare cancer, with a lack of reliable treatment options.

During an ongoing phase 2 trial, tazemetostat, intended to treat epithelioid sarcoma that has spread to other parts of the body but cannot be addressed with surgery, reduced disease in 11% to 15% of patients.

Tazemetostat is also being evaluated as a treatment for follicular lymphoma, a cancer that affects white blood cells.