The world's first oral PI3K/CK1 inhibitor once a day has been approved by the FDA for the treatment of lymphoma

TG corporation announced that the U.S. FDA has approved the listing of umbralisib (trade name UKONIQ) for treatment of adult patients who have previously received at least one recurring or refractic marginal lymphoma (MZL) based on an anti-CD20 treatment and adult patients with recurring or refractic filter lymphoma (FL) who have previously received at least three-line systemic therapy.
Umbralisib is the first and only approved 1 oral phosphate inositol 3 kinase δ (PI3K) and casein kinase 1 (CK1) ε inhibitors.
PI3K-δ play an important role in supporting cell proliferation and survival, cell differentiation, intercellular transport, and immunity, both in normal and malignant b cells.
CK1-ε is a cancer protein translation regulatory factor associated with the pathogenesis of cancer cells, including lymphatic malignancies.
previously, umbralisib's treatment of MZL adaptation had been recognized by the FDA as a breakthrough therapy and the listing application had been included in the priority review.
umbralisib was also awarded the Orphan Drug Identification (ODD) for the treatment of MZL and FL.
approval of MZL and FL adaptations is based on total mitigation rate (ORR) data from a Phase II UNITY-NHL (NCT02793583) study.
UNITY-NHL study was an open-label, multi-center, two-queue study in which 69 MZL patients and 117 FL patients were recruited and subjects were treated with umbralisib (800 mg) once a day or oral until the disease progressed or benitible.
results show that the total remission rate (ORR) of MZL patients is 49%, the total remission rate (CR) is 16%, and the medium remission duration (DOR) has not yet been reached.
FL patients were 43%, CR was 3.4% and DOR was 11.1 months.
Analysis of safety data from 221 MZL and FL adult patients treated with umbralisib for 3 single-arm, open-label trials and 1 open-label extended trial showed that 18 per cent of patients treated with umbralisib had severe adverse reactions, with a incidence of >2 per cent of serious adverse reactions including diarrhoea-colitis (4 per cent), pneumonia (3 per cent), sepsis (2 per cent) and urinary tract infections (2 per cent).
Lymphoma (MZL) is a group of inert (slow-growing) mature B-cell non-Hodgkin's lymphoma (NLS), the second most common type of B-cell NHL, accounting for about 10% of all NHL cases.
MZL includes 3 subsypes of lymphoma (SMZL), mucosal-related lymphatic tissue (MALT type) lymphoma, and lymph node edge lymphoma (NMZL).
MZL is generally considered a chronic incurable disease, with about 8,200 newly diagnosed patients in the United States each year.
FL is a typical inert non-Hodgkin's lymphoma (NHL) that originates in B lymphocytes.
the second most common form of NHL, accounting for about 17 percent of all NHL cases, with about 13,200 newly diagnosed patients in the United States each year.
FL is usually incurable because patients with this form of lymphoma can survive for many years and are therefore considered a chronic disease.
Nathan Fowler, a professor of medicine at the University of Texas Anderson Cancer Center, said that despite some progress in the treatment of MZL and FL, it is still an incurable disease.
options for patients who have relapsed after treatment in the past are limited and there are no clear criteria for treatment.
approval of umbralisib gives us a targeted, oral, once-a-day choice that patients need.
Pick-up Source: Pharmaceutical Rubik's Cube Copyright Notice: All text, images and audio and video materials on this website that indicate "Source: Met Medical" or "Source: MedSci Original" are owned by Mace Medical and may not be reproduced by any media, website or individual without authorization, and shall be reproduced with the words "Source: Mets Medicine".
all reprinted articles on this website are for the purpose of transmitting more information and clearly indicate the source and author, and media or individuals who do not wish to be reproduced may contact us and we will delete them immediately.
at the same time reproduced content does not represent the position of this site.
leave a message here