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The drug’s indication for marginal zone lymphoma (MZL) may not be approved until February 2021.
FDA accepted the new Drug Application (NDA) for umbralisib (TG Therapeutics), an investigational treatment for marginal zone lymphoma (MZL) and follicular lymphoma (FL).
The once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon is for patients with previously treated MZL who have received at least one prior anti-CD20 based regimen and FL who have received at least two prior systemic therapies.
The MZL indication has a Prescription Drug User Fee Act (PDUFA) goal date of February 15, 2021, while the indication for FL has been accepted for standard review with a PDUFA goal date of June 15, 2021.
The NDA for umbralisib was based primarily on data from the umbralisib monotherapy MZL and FL cohorts of a Phase 2b trial. TG Therapeutics announced last year that each cohort met its primary endpoint of overall response rate (ORR), meeting the company’s target guidance of 40 to 50% ORR, as confirmed by an Independent Review Committee.
“If approved, we believe umbralisib could become an important treatment option for patients with previously treated MZL and FL,” said Michael S. Weiss, executive chairman and CEO of TG Therapeutics in a press release. “This is a significant achievement in our path towards accomplishing our goal of developing novel treatments for patients with B-cell diseases.”
FDA also recently approved the first-cell-based gene therapy to treat mantle cell lymphoma (MCL).
Brexucabtagene autoleucel (Tecartus, Kite, a Gilead company), a chimeric antigen receptor (CAR) T cell therapy, received Priority Review and Breakthrough Therapy Designation by FDA.