Ublituximab: SPA received

TG Therapeutics said it received an SPA from FDA for a Phase III trial to compare IV ublituximab plus Imbruvica ibrutinib vs. Imbruvica alone in about 330 previously treated patients with CLL. The company plans to use ORR data from the trial, which is slated to start by year end, to support accelerated approval of a BLA for ublituximab, while PFS data are expected to support full approval. Ublituximab has Orphan Drug designation in the EU and the U.S. for B cell CLL and Orphan Drug designation in the U.S. to treat nodal marginal zone lymphoma and to treat extranodal marginal zone lymphoma (mucosa-associated lymphatic tissue), which are both rare subtypes of non-Hodgkin's lymphoma (NHL).

The company also said it completed enrollment of the CLL cohort in a Phase II trial evaluating ublituximab in combination with Imbruvica in patients with CLL and mantle cell lymphoma (MCL). TG Therapeutics expects to have over 30 CLL patients evaluable for safety and efficacy to present at the American Society of Hematology meeting in San Francisco in December. ...