Posted by Michael Wonder on 18 Jun 2020
FDA granted accelerated approval to tazemetostat for follicular lymphoma
18 June 2020 - Today the Food and Drug Administration granted accelerated approval to tazemetostat (Tazverik, Epizyme), an EZH2 inhibitor, for adult patients with relapsed or refractory follicular lymphoma whose tumours are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies, and for adult patients with relapsed/refractory follicular lymphoma who have no satisfactory alternative treatment options.
Today, the FDA also approved the cobas EZH2 Mutation Test (Roche Molecular Systems) as a companion diagnostic for tazemetostat.
