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The FDA has granted Priority Review to the New Drug Application for tazemetostat as treatment for patients with relapsed or refractory follicular lymphoma who have received at least 2 prior lines of systemic therapy. The drug will now be considered for accelerated approval and the application was designation as a supplemental NDA with a Prescription Drug User Fee Act target action date of June 18, 2020, Epizyme, Inc announced in a press release.

Next-generation sequencing in patients with chronic lymphocytic leukemia treated with the combination of chlorambucil and ofatumumab showed that the presence of TP53, SF3B1, and NOTCH1 mutations were predictive of reduced efficacy, according to the results of the phase III COMPLEMENT1 trial published in Haematologica.

In January 2020, the FDA approved new treatment options in gastrointestinal stromal tumors, bladder cancer, and epithelioid sarcoma. The FDA also granted several Priority Review Designations, orphan drug designations, and a Fast Track designation, as well as a Breakthrough Therapy designation.

Following the FDA approval of gemtuzumab ozogamicin with induction and consolidation therapy in newly diagnosed CD33-positive acute myeloid leukemia, investigators led by Richard F. Schlenk, MD, hypothesized that patients with NPM1-mutated acute myeloid leukemia, which occurs in 20% to 30% of the patient population, could also derive benefit from gemtuzumab.