FDA accelerates approval of innovative PI3K inhibitors to treat lymphoma

Marginal lymphoma is a group of slow-growing B-cell non-Hodgkin's lymphoma (NHL).
is the third most common B-cell NHL, accounting for about 8% of all NHL cases.
lymphoma is the most common inert lymphoma, accounting for about 20% of all NHL cases.
previous studies have shown that PI3K pythons play an important role in supporting cell proliferation and survival, cell differentiation, intercellular transport, and immunity, both in normal and malignant B cells.
CK1 is the regulatory factor for the translation of carcinogenic proteins and is related to the mechanism of occurrence of cancer cells, including lymphatic malignancies.
ukoniq had been identified as a breakthrough therapist for lymphoma in marginal areas.
approval was supported by an open-label Phase 2b clinical trial called UNITY-NHL.
in patients with marginal lymphoma (MZL), Ukoniq achieved an objective remission rate (ORR) of 49%, including a full remission rate of 16%, and the medium remission duration (DOR) had not yet been achieved.
in patients with folytic lymphoma (FL), Ukoniq had 43% ORR and a medium DOR of 11.1 months.
S. Weiss, Executive Chairman and CEO of TG Therapeutics, said, "We are delighted to be able to bring this innovative inhibitor of PI3K and CK1 to patients with relapsed/refrectable MZL and FL.
we would like to thank patients, doctors, nurses and clinical coordinators for their support and participation in our clinical trials.
we remain committed to developing new treatment options for patients with B-cell disease.
: This article is intended to introduce medical and health research, not treatment options recommended.
if you need guidance on treatment options, visit a regular hospital.
references: TG Therapeutics Announcs FDA Accelerated Approval of UKONIQ ™ (umbralisib). Retrieved February 5, 2021, from