Ublituximab-Umbralisib Combo for CLL Receives Fast Track Designation

The mission of biopharmaceutical company TG Therapeutics, Inc. (“TG”) has always been to create treatments to fulfill unmet needs for patients. Their focus is on autoimmune disorders and B-cell malignancies. Now, they are making steps in the right direction with the U2 combination. According to a recent press release, the combination of ublituximab and umbralisib, designed to treat patients with chronic lymphocytic leukemia (CLL), recently received Fast Track designation from the FDA.


The FDA’s Fast Track designation helps to more quickly develop and review therapies designed to treat patients with rare or serious conditions, or patients with conditions that have few treatment options. When a therapy receives this status, the drug developer is allowed Priority Review, rolling submission for other applications, and more frequent FDA communication.

Ublituximab is an investigational glycoengineered anti-CD20 monoclonal antibody. The American Cancer Society defines monoclonal antibodies as man-made proteins that act like antibodies in your immune system. Umbralisib, on the other hand, is an orally administered PI3K-delta and CK1-epsilon inhibitor. Together, they are designed to treat patients with CLL.

The combination received Fast Track designation following data from the Phase 3 UNITY-CLL clinical trial. Patients had either treatment-naive (never before treated) or relapsed or refractory CLL. 420 patients enrolled. During the trial, patients were put into one of four groups:

  • Only receiving ublituximab
  • Receiving ublituximab and umbralisib
  • Only receiving umbralisib
  • Receiving obinutuzumab and chlorambucil

The fourth arm can be considered a control. Of these groups, a majority of patients had treatment-naive CLL. Ultimately, the trial determined that patients receiving both ublituximab and umbralisib had better outcomes and less disease progression than other groups.

Chronic Lymphocytic Leukemia (CLL)

Doctors are still unclear on the exact cause of chronic lymphocytic leukemia (CLL), a cancer that affects the blood and bone marrow. However, they do know that some sort of genetic mutation occurs in blood-producing cell DNA. As a result, your body creates abnormal and deficient lymphocytes, a type of white blood cell. These crowd out healthy white blood cells, causing health issues. In adults, CLL is the second most common form of leukemia.

Symptoms of CLL include:

  • Unintended weight loss
  • Fatigue
  • Fever
  • Abdominal pain
  • Spleen enlargement
  • Frequent infections
  • Swollen lymph nodes
  • Night sweats

Learn more about CLL.

Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

Share this post

Share on facebook
Share on google
Share on twitter
Share on linkedin
Share on pinterest
Share on print
Share on email