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FDA Orders Partial Hold on Tazemetostat

December 30, 2021

The U.S. Food and Drug Administration suspended enrollment for all clinical trials of the EZH2 inhibitor tazemetostat following a report that a pediatric patient participating in a phase I study developed a secondary lymphoma.

According to a statement from Epizyme, the drug's manufacturer, "At the time of the safety report, the patient had been on study for approximately 15 months and had achieved a confirmed partial response. This patient has now discontinued tazemetostat and is being treated for T-cell lymphoma."

The EZH2 inhibitor is being studied as a monotherapy in ongoing phase I and II trials of follicular lymphoma and diffuse large B-cell non-Hodgkin lymphoma.

Source: Endpoint News, April 23, 2018; Epizyme press release, April 23, 2018.

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