TG aims for accelerated approval of lymphoma candidate

TG Therapeutics Inc. (NASDAQ:TGTX) said umbralisib (TGR-1202) met the primary endpoint in a cohort of marginal zone lymphoma patients in a pivotal Phase IIb trial. The biotech now plans to seek accelerated approval of the PI3Kδ inhibitor.

Among the cohort's 69 patients with relapsed/refractory marginal zone lymphoma in the UNITY-NHL trial, TG said once-daily oral umbralisib met the primary endpoint of improving overall response rate (ORR) by achieving a response rate within the company's guidance of 40-50%. Patients in the cohort received at least one prior anti-CD20 regimen...