US FDA accelerated approval of tazemetostat for relapsed/refractory follicular lymphoma (R/RFL)

Tazemetostat has been approved in the US for the treatment of 1) adults with R/RFL with tumours that are positive for an EZH2 mutation and who have received at least two prior systemic therapies, and 2) adults with R/RFL who have no satisfactory alternative treatment options.

SPS commentary:

Tazemetostat is a first-in-class EZH2 epigenetic enzyme inhibitor. Accelerated approval of its use for these two indications was based on overall response rate and duration of response in Phase 2 clinical trial cohorts of FL patients with EZH2 mutations and wild-type EZH2. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). It is under Phase II development in the EU for the treatment of follicular lymphoma and epithelioid sarcoma.


Biospace Inc.