Is ibrutinib/ibrutinib on the market?

Ibrutinib/Ibrutinib is a small molecule drug that acts as an irreversible and potent inhibitor of Burton's tyrosine kinase. It is designated as a targeted covalent drug and has been shown to have promising activity in B-cell malignancies in clinical trials. Ibrutinib, developed by Pharmacyclics Inc, was first approved by the U.S. Food and Drug Administration (FDA) for accelerated approval for the treatment of mantle cell lymphoma (MCL) in November 2013; however, in April 2023, the drug manufacturer withdrew ibrutinib's accelerated approval in the United States.

Ibrutinib was effective in slowing the progression of chronic lymphocytic leukemia in both untreated and previously treated patients. Additionally, ibrutinib is effective in patients with mantle cell lymphoma who have failed to respond to or relapsed from prior therapy, a group of patients with a poor prognosis and few other treatment options. In addition, ibrutinib was shown to be effective in patients with Waldenströ's macroglobulinemia. The side effects of this drug are considered acceptable.

Ibrutinib was approved by the European Medicines Agency (EMA) in October 2014, and by Health Canada in November 2014. It was also approved by the National Medical Products Administration in January 2022 for marketing in China, and is sold under the trade name IMBRUVICA. Currently, ibrutinib has been approved in August 2017 for the treatment of multiple diseases, such as chronic lymphocytic leukemia (CLL), Waldenstrom's macroglobulinemia (WM) and chronic graft-versus-host disease (cGVHD). Notably, ibrutinib became the first FDA-approved treatment for cGVHD in children in August 2017.