Ukoniq™ (umbralisib) Receives Accelerated Approval for Adults with Marginal Zone Lymphoma and Follicular Lymphoma

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Ukoniq™ (umbralisib) for certain adults with marginal zone lymphoma (MZL) and follicular lymphoma (FL).¹

Umbralisib is approved for use in people with MZL or FL that has relapsed after a previous treatment or not responded to treatment. Those with MZL must have been previously been treated with an anti-CD20-based regimen before starting umbralisib. Those with FL must have previously had at least 3 systemic therapies.^1,2

Accelerated approval is granted to new drugs that are very promising and could make a positive impact on the treatment of serious conditions. There have been limited options for people with MZL or FL whose cancer had come back after treatment (known as recurrence or relapse). Umbralisib may be a new treatment option to help these people.²

The company that makes umbralisib, TG Therapeutics, is hoping to make the drug available in the United States soon.^1,2

How does umbralisib work?

Umbralisib is a type of drug called a kinase inhibitor. Kinase is an enzyme that can have many jobs in healthy cells. However, kinase can be very active in certain types of cancer cells. A kinase inhibitor can block the kinase. This may prevent cancer cells or tumors from growing.⁴

Umbralisib is the first and only inhibitor of 2 specific kinases. The kinases that umbralisib targets are:²

• Phosphoinositide 3 kinase delta (PI3K-delta), which plays a role in cell division and survival
• Casein kinase 1 epsilon (CK1-epsilon), which plays a role in the development of cancer cells

By blocking these kinases, umbralisib may help slow the growth of cancer cells.²

Evidence for umbralisib

Umbralisib was approved based on results from a clinical trial. The researchers studied 2 groups of people: 69 with MZL, and 117 with FL.¹

They found that about 50 percent of the people with MZL had a positive response to umbralisib. About 40 percent of the people with FL had a positive response to umbralisib. A positive response means their cancer shrank or disappeared after treatment with the drug.¹

What are the possible side effects of umbralisib?

The most common side effects of umbralisib include:³

• Diarrhea, vomiting, or nausea
• Tiredness
• Low red blood cell count (anemia)
• Low platelet count
• Upper respiratory tract infection
• Muscle or bone pain

These are not all the possible side effects of umbralisib. Talk to your doctor about what to expect or if you experience any changes that concern you during treatment with umbralisib.

Things to know about umbralisib

Umbralisib may cause an allergic reaction in people who are allergic to FD&C Yellow N0. 5.³

Umbralisib can harm an unborn baby. Women who can become pregnant and men with partners who can become pregnant should use birth control (contraception) during treatment and for a period of time after the last dose of umbralisib. Talk to your doctor about the right birth control options and how long you need to use them. Women should also not breastfeed during treatment with umbralisib and for a period of time after the last dose. Talk to your doctor about the right breastfeeding options.³

For more information, read the full prescribing information of umbralisib.