TG Therapeutics Reports SPA Agreement With FDA For Phase 3 Trial Of TG-1101

(RTTNews) - TG Therapeutics, Inc. (TGTX) Monday said according to a Special Protocol Assessment or SPA agreement it signed with the U.S. Food and Drug Administration or FDA, the company's first Phase 3 trial design adequately addresses objectives that would support the regulatory submission of its drug TG-1101's approval. As per the SPA, the company plans to use the Overall Response Rate or ORR data from the trial as the basis for submission of a Biologics License Application for accelerated approval of TG-1101. All patients will then be followed for Progression-Free Survival assessment, which aims to support full approval. The trial will enroll nearly 330 patients, with about the first two-thirds of the patients included in the ORR assessment. The company expects launch of the study before the end of the year.