FDA accepts BLA for ublituximab + Ukoniq in leukemia and lymphoma indications

The US Food and Drug Administration has accepted the Biologics License Application (BLA) for ublituximab, an investigational glycoengineered anti-CD20 monoclonal antibody, in combination with Ukoniq (umbralisib), TG Therapeutics’ (Nasdaq: TGTX) once-daily, oral, inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 25, 2022. The FDA also notified the company that it is not currently planning to hold an advisory committee meeting to discuss this application.

In February this year, the FDA approved Ukoniq for adult patients with relapsed or refractory marginal zone lymphoma (MZL). According to Evaluate Vantage at that time, Ukoniq should achieve annual sales of $254 million by 2026. An FDA decision is also set for June for umbralisib in follicular lymphoma, while a bigger opportunity lies ahead with a combination with ublituximab, an anti-CD20 antibody, said Evaluate Vantage.