FDA grants fast track designation to EZM0414 for diffuse large B-cell lymphoma
Click Here to Manage Email Alerts
The FDA granted fast track designation to EZM0414 for treatment of adults with relapsed or refractory diffuse large B-cell lymphoma.
EZM0414 (Epizyme) is an oral SETD2 inhibitor. SETD2 is a histone methyltransferase that plays several important roles in oncogenesis, according to an Epizyme-issued press release.
The company has launched a phase 1/1b study to assess the safety of the agent and determine the optimal dose. After the dose-ranging phase, the study will be expanded to include three cohorts: patients with multiple myeloma and translocation t(4;14), multiple myeloma without translocation t(4;14) and DLBCL.
“The receipt of fast track designation underscores the urgent need for innovative therapies that may significantly improve the lives of patients living with devastating diseases such as DLBCL,” Shefali Agarwal, MD, executive vice president and chief medical and development officer at Epizyme, said in the release. “Additionally, through the initiation of our phase 1/1b study, we look forward to evaluating the safety and efficacy of EZM0414 in both DLBCL and multiple myeloma, including high-risk t(4;14) multiple myeloma. [Patients with multiple myeloma] with this high-risk mutation often have a poorer prognosis, and [this] is an area of high unmet medical need.”
Read more about
Click Here to Manage Email Alerts