FDA Approval Sought for Tazemetostat in Follicular Lymphoma

December 19, 2019 – A new drug application (NDA) has been submitted to the FDA for tazemetostat as a treatment for patients with relapsed/refractory follicular lymphoma, with or without EZH2 activating mutations, who have received ≥2 prior lines of systemic therapy. The submission, which is for an accelerated approval, is mostly based on updated results of an ongoing phase II trial, which showed that the first-in-class EZH2 inhibitor elicited an objective response … (leggi tutto)