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FDA grants fast track designation to tazemetostat for follicular lymphoma

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The FDA granted fast track designation to tazemetostat for the treatment of patients with relapsed or refractory follicular lymphoma, according to the drug’s manufacturer.

The designation applies use of tazemetostat (Epizyme) regardless of whether patients harbor EZH2 mutations.

“This is an important milestone for our non-Hodgkin lymphoma program,” Robert Bazemore, president and CEO of Epizyme, said in a company-issued press release.

The FDA previously granted fast track designation to tazemetostat for treatment of relapsed or refractory diffuse large B-cell lymphoma with EZH2 activating mutations. The FDA also granted orphan drug designation to the agent for treatment of malignant rhabdoid tumors.

Ongoing phase 2 study programs are evaluating tazemetostat — a first-in-class EZH2 inhibitor — for the treatment of follicular lymphoma, DLBCL, certain genetically defined solid tumors, and mesothelioma.