Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Drugs
Published in: Drugs 4/2021

01-03-2021 | Lymphoma | AdisInsight Report

Orelabrutinib: First Approval

Author: Sohita Dhillon

Published in: Drugs | Issue 4/2021

Login to get access

Abstract

Dysregulation of Bruton's tyrosine kinase (BTK) signalling has been linked to various B cell malignancies and autoimmune diseases. Orelabrutinib (宜诺凯®) is an orally administered, potent, irreversible and highly selective BTK-inhibitor being developed by InnoCare Pharma for the treatment of B cell malignancies and autoimmune diseases. In December 2020, orelabrutinib received its first approval in China for the treatment of patients with mantle cell lymphoma (MCL) or chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL), who have received at least one treatment in the past. Clinical development of orelabrutinib for various indications is underway in the USA and China. This article summarizes the milestones in the development of orelabrutinib leading to this first approval.
Literature
1.
Vargas L, Hamasy A, Nore BF, et al. Inhibitors of BTK and ITK: state of the new drugs for cancer, autoimmunity and inflammatory diseases. Scand J Immunol. 2013;78(2):130–9.CrossRef
2.
Lorenzo-Vizcaya A, Fasano S, Isenberg DA. Bruton’s tyrosine kinase inhibitors: a new therapeutic target for the treatment of SLE? Immunotargets Ther. 2020;9:105–10.CrossRef
3.
Pal Singh S, Dammeijer F, Hendriks RW. Role of Bruton’s tyrosine kinase in B cells and malignancies. Mol Cancer. 2018;17(1):57.CrossRef
4.
Zarrin AA, Bao K, Lupardus P, et al. Kinase inhibition in autoimmunity and inflammation. Nat Rev Drug Discov. 2021;20(1):39–63.CrossRef
5.
Shaw ML. Second-generation BTK inhibitors hit the treatment bullseye with fewer off-target effects. Am J Manag Care. 2020;26(7 Spec No.):SP226–7.
6.
7.
InnoCare Pharma Ltd. Orelabrutinib: Chinese prescribing information. Beijing: Innocare Pharma Ltd.; 2021.
8.
Zhang B, Zhao R, Liang R, et al. Orelabrutinib, a potent and selective Bruton's tyrosine kinase inhibitor with superior safety profile and excellent PK/PD properties [abstract no. CT132]. In: Proceedings American Association for Cancer Research Annual Meeting. 2020.
9.
Song Y, Liu L, Zhang M, et al. Safety and efficacy of orelabrutinib monotherapy in Chinese patients with relapsed or refractory mantle cell lymphoma: a multicenter, open-label, phase II study [abstract no. 755]. Blood 2019;134(Suppl. 1).
10.
Song Y, Song Y, Liu L, et al. Long-term safety and efficacy of orelabrutinib monotherapy in Chinese patients with relapsed or refractory mantle cell lymphoma: a multicenter, open-label, phase II study [abstract]. Blood. 2020;136(Suppl. 1):1.CrossRef
11.
Xu W, Song Y, Li Z, et al. Safety, tolerability and efficacy of orelabrutinib, once a day, to treat Chinese patients with relapsed or refractory chronic lymphocytic leukemia/small cell leukemia [abstract]. Blood. 2019;134(Suppl. 1):4319.
12.
Xu W, Song Y, Wang T, et al. Updated results from the phase II study of orelabrutinib monotherapy in Chinese patients with relapsed or refractory chronic lymphocytic leukemia/ small cell leukemia [abstract]. Blood. 2020;136(Suppl. 1):26–7.CrossRef
13.
Song Y, Xu W, Liu L, et al. Pooled analysis of safety data from clinical trials of orelabrutinib monotherapy in hematologic malignancies [abstract]. Blood. 2020;136(Suppl. 1):43.CrossRef
Metadata
Title
Orelabrutinib: First Approval
Author
Sohita Dhillon
Publication date
01-03-2021
Publisher
Springer International Publishing
Published in
Drugs / Issue 4/2021
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-021-01482-5

Other articles of this Issue 4/2021

Drugs 4/2021 Go to the issue

Review Article

Detecting and Targeting NTRK Fusions in Cancer in the Era of Tumor Agnostic Oncology

Original Research Article

Personalized Multimorbidity Management for Patients with Type 2 Diabetes Using Reinforcement Learning of Electronic Health Records

Review Article

Novel Therapy Approaches to Follicular Lymphoma

Current Opinion

Understanding the Chameleonic Breakthrough Cancer Pain

Leading Article

Strategies Targeting the Innate Immune Response for the Treatment of Hepatitis C Virus-Associated Liver Fibrosis

Adis Drug Evaluation

Secukinumab: A Review in Psoriatic Arthritis