The U.S. Food and Drug Administration (FDA) has granted Fast Track status to Epizyme‘s tazemetostat as a potential treatment for relapsed or refractory follicular lymphoma patients with or without EZH2 activating mutations, the company announced.
This is the second Fast Track designation given tazemetostat. The first was for patients with diffuse large B-cell lymphoma (DLBCL) with EZH2 activating mutations. Fast Track is designed to expedite the development and review of important new drugs under study, potentially making them available to patients more quickly.
Tazemetostat is an orally administered first-in-class EZH2 inhibitor that has shown anti-tumor activity and a well-tolerated safety profile in early clinical trials for patients with blood and solid cancers.
Epizyme is evaluating the therapy as a single agent in multiple clinical trials. They include its use against DLBCL and follicular lymphoma (FL), both non-Hodgkin lymphoma subtypes, and in certain genetically defined solid tumors, such as BAP-mutant mesotheliomas (NCT02860286).
The company is assessing tazemetostat in combination with R-CHOP chemotherapy as a first-line therapy for newly diagnosed and high-risk, older DLBCL patients (NCT02889523), and in combination with Tecentriq (atezolizumab) for people with relapsed or refractory DLBCL or FL (NCT02220842). Both trials are currently recruiting patients.
Epizyme said it will present interim effectiveness and safety data from the five cohorts in its ongoing Phase 2 trial in relapsed or refractory FL and DLBCL at the 14th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland, on June 14.
The company will also present data from a biomarker study of tazemetostat in non-Hodgkin lymphoma patients during a poster session at the conference.
“This is an important milestone for our NHL program, with tazemetostat now having FDA Fast Track designation for relapsed or refractory diffuse large B-cell lymphoma with EZH2 activating mutations and for relapsed or refractory follicular lymphoma, regardless of EZH2 mutation,” Robert Bazemore, president and chief executive officer of Epizyme, said in a news release. “Our development goal is to bring tazemetostat to patients as quickly as possible, and we look forward to advancing this study throughout 2017.”
The Phase 1 study in relapsed or refractory DLBCL or FL (NCT02220842) patients is taking place at numerous sites across the United States in several European countries. The R-CHOP trial (NCT02889523) is being conducted at sites throughout France. More information is available by clicking on each trial’s identification number.