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FDA grants fast track designation to tazemetostat for diffuse large B-cell lymphoma
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The FDA granted fast track designation to tazemetostat for the treatment of patients with diffuse large B-cell lymphoma with EZH2 activating mutations, according to the drug’s manufacturer.
In addition, the drug’s manufacturer announced it expanded enrollment in the epithelioid sarcoma cohort of a phase 2 registration-enabling study of tazemetostat (Epizyme) — a first-in-class EZH2 inhibitor — in adults with genetically defined solid tumors with loss of INI1.
“We are very proud of the continued advancement of our tazemetostat clinical program in both non-Hodgkin lymphoma and genetically defined solid tumors, important areas of unmet medical need for patients with cancer,” Robert Bazemore, president and CEO of Epizyme, said in a press release.
Tazemetostat is being evaluated as a monotherapy and in combination with R-CHOP — an immuno-chemotherapy regimen consisting of rituximab (Ritxuan; Genentech, Biogen), cyclophosphamide, doxorubicin, vincristine and prednisone — and with atezolizumab (Tecentriq, Genentech), an anti–PD-L1 cancer immunotherapy.
“These developments reflect the execution of our strategy to identify the patient groups who may benefit most from tazemetostat, and our efforts to bring this investigational medicine to patients as quickly as possible,” Bazemore said.