FDA fast tracks investigational leukemia treatment

TG Therapeutics was granted FDA Fast Track Designation for its investigational treatment for chronic lymphocytic leukemia (CLL).

The treatment is a combination of ublituximab, its investigational glycoengineered anti-CD20 monoclonal antibody, and umbralisib, the company’s investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon.

Related: FDA grants full approval for combination leukemia treatment​

The application for Fast Track was based on data from the UNITY-CLL Phase 3 study that TG announced earlier this year had met its primary endpoint of progression free survival.

"We are extremely pleased to have received Fast Track designation for the ublituximab plus umbralisib regimen, or the U2 combination, to treat adult patients with CLL,” said Michael S. Weiss, executive chairman and CEO of TG Therapeutics, in a press release.

“This designation holds several important advantages to potentially expedite the development and regulatory review of U2 and underscores the significant unmet medical need that still exists for patients with CLL.” Weiss said.

Related: FDA approves new indication for leukemia drug​

UNITY-CLL is a global Phase 3 randomized controlled clinical trial comparing the U2 combination to an active control arm of obinutuzumab plus chlorambucil in patients with both treatment-naïve and relapsed or refractory chronic lymphocytic leukemia (CLL).

The trial enrolled approximately 60% treatment-naïve CLL patients and 40% relapsed or refractory CLL patients.

In related news, FDA recently granted full approval of venetoclax (Venclexta, Genentech) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC)to treat acute myeloid leukemia (AML).

Venclexta, specifically designated to treat newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older or who have comorbidities that preclude use of intensive induction chemotherapy, was previously granted provisional approval under FDA’s accelerated approval program in late 2018.

Read more: FDA clears oral leukemia drug​