FDA fast tracks investigational leukemia treatment
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.
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
FDA Approves Two More Denosumab Biosimilars, Conexxence and Bomyntra
March 27th 2025The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, as a result of a global settlement with Amgen, according to a company news release.
Read More
FDA Approves First Drug for Excess Hunger in Prader-Willi Syndrome
March 27th 2025Vykat XR will be available in April to treat the intense hunger that is a hallmark of the rare genetic disease Prader-Willi syndrome. The price is based on a patient’s weight, and the average patient in the clinical trials would have had an average annual cost of $466,200 for the first year.
Read More
FDA Approves Amvuttra for ATTR-CM in Extended Label
March 21st 2025This expanded indication for Amvuttra makes it the first and only FDA-approved treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.
Read More
