Posted by Michael Wonder on 19 Dec 2019
Epizyme submits new drug application to the U.S. FDA for tazemetostat for the treatment of patients with follicular lymphoma
18 December 2019 - Submission marks on-time execution of second submission for tazemetostat in 2019.
Epizyme today announced that it has submitted a new drug application to the U.S. FDA for accelerated approval of tazemetostat for the treatment of patients with relapsed or refractory follicular lymphoma (FL), both with or without EZH2 activating mutations, who have received at least two prior lines of systemic therapy.
Epizyme’s FL submission follows a pre-NDA meeting held with FDA in October 2019, in which the Agency indicated that it considered the proposed clinical package to be sufficient for inclusion as part of the NDA for accelerated approval.
