Posted by Michael Wonder on 25 Apr 2017
Epizyme announces tazemetostat fast track designation for follicular lymphoma and plenary session on Phase 2 NHL data at ICML
25 April 2017 - Interim efficacy and safety data from ongoing Phase 2 study in follicular lymphoma and DLBCL selected for plenary presentation at the International Conference on Malignant Lymphoma.
Epizyme today announced that the U.S. FDA has granted fast track designation to tazemetostat, the company's first-in-class EZH2 inhibitor, for the treatment of patients with relapsed or refractory follicular lymphoma, either wild type EZH2 or with EZH2 activating mutations.
Tazemetostat, a first-in-class EZH2 inhibitor, is currently being studied in ongoing Phase 2 programs in both follicular lymphoma and diffuse large B-cell lymphoma (DLBCL) forms of non-Hodgkin lymphoma; certain genetically defined solid tumors, including INI1-negative and SMARCA4-negative tumors and synovial sarcoma; and mesothelioma, as well as in combination studies in DLBCL. Tazemetostat has been granted Fast Track designation by the U.S. Food and Drug Administration for both relapsed/refractory follicular lymphoma with or without an EZH2 activating mutation and DLBCL with EZH2 activating mutations, as well as Orphan Drug designation for malignant rhabdoid tumors.
