In June 2020, the FDA approved tazemetostat (Tazverik) for 2 distinct follicular lymphoma indications based on overall response rate and duration of response observed in phase 2 clinical trial cohorts of patients with follicular lymphoma with EZH2 mutations and wild-type EZH2.
In June 2020, the FDA approved tazemetostat (Tazverik) for 2 distinct follicular lymphoma (FL) indications, including for adult patients with relapsed or refractory FL whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies, as well as for adult patients with relapsed or refractory FL who have no satisfactory alternative treatment options.
The supplemental new drug application for these indications was approved under accelerated approval with a priority review based on overall response rate and duration of response observed in phase 2 clinical trial cohorts of patients with FL with EZH2 mutations and wild-type EZH2 conducted by Epizyme. However, continued approval for these indications may be dependent upon verification and description of clinical benefit in a confirmatory trial(s).
“Follicular lymphoma remains an incurable disease, and even with the availability of new drugs in recent years, there have remained important unmet needs in the treatment of follicular lymphoma,” study investigator John P. Leonard, MD, the Richard T. Silver Distinguished Professor of Hematology and Medical Oncology at Weill Cornell Medicine and an oncologist at NewYork-Presbyterian/Weill Cornell Medical Center, said in a press release. “The durable responses observed with this drug are notable in the context of the safety profile and route of oral, at-home administration, and will offer an important new option for physicians as we care for patients with relapsed/refractory follicular lymphoma.”
In an interview with CancerNetwork®, Leonard discussed the approval of tazemetostat for this indication and what the approval of this agent may provide for individuals with follicular lymphoma.
This segment comes from the CancerNetwork® portion of the MJH Life Sciences Medical World News, airing daily on all MJH Life Sciences channels.
Epizyme Announces U.S. FDA Accelerated Approval of TAZVERIK™ (tazemetostat) for Relapsed/Refractory Follicular Lymphoma [news release]. Cambridge, Massachusetts. Published June 18, 2020. Accessed October 26, 2020. https://www.businesswire.com/news/home/20200618005820/en/%c2%a0Epizyme-Announces-U.S.-FDA-Accelerated-Approval-TAZVERIK%E2%84%A2