CAS 936563-96-1

General Information

Ibrutinib is an orally administered anticancer drug for the treatment of mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL) and Waldenstrm’s macroglobulinemia (WM ‘ also known as lymphoplasmacytic lymphoma).

Teva API looked to co-crystals as a means to create a new generic alternative to Imbruvica® (Ibrutinib), a widely prescribed anticancer drug.

Ibrutinib has been reported to promote self-destruction (apoptosis) of malignant B-cells, inhibit their proliferation, and also prevent them from responding to survival stimuli provided by the tumor microenvironment. In mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL), ibrutinib can be used in patients who have received at least one prior therapy without success. For the treatment of Waldenstrm’s macroglobulinemia or CLL with 17p deletion (a certain mutation) there is no such requirement.

Under the trade name Imbruvica, ibrutinib was approved by the FDA in 2013 for the treatment of MCL, and in 2014 for the treatment of CLL. In 2015, ibrutinib was approved for treatment of WM. It is produced through multi-step chemical synthesis.

About the API

Trade name(s) Imbruvica
Technology Synthetic Organic Chemistry
Therapeutic category Oncology
Available formulations Oral Solid
Regulations US DMF Flag US DMF