FDA Places Partial Clinical Hold on Studies of Umbralisib and Ublituximab in CLL and NHL

The US Food and Drug Administration (FDA) has placed a partial clinical hold on trials evaluating umbralisib and ublituximab for the treatment of chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL). Until the hold is resolved, no new patients will be enrolled in these studies, but patients currently enrolled who are deriving benefit may continue treatment with consent.

Umbralisib, an oral inhibitor of phospoinositide 3 kinase (PI3K) delta and casein kinase 1 epsilon, received accelerated approval from the FDA for the following indications:

• adults with relapsed/refractory marginal zone lymphoma who have received at least 1 previous anti-CD20–based regimen
• adults with relapsed/refractory follicular lymphoma who have received at least 3 previous systemic therapies

Ublituximab is an investigational glycoengineered monoclonal antibody targeting a unique epitope on CD20-expression B-cells.

According to TG Therapeutics CEO Michael Weiss, the agency’s concerns will be addressed at the FDA’s Oncologic Drugs Advisory Committee meeting in spring 2022.

Source: TG Therapeutics press release, Jan. 27, 2022.