Janssen-Cilag International NV (Janssen) announced today it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ibrutinib for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) or relapsed or refractory mantle cell lymphoma (MCL), two forms of blood cancer.
Ibrutinib is administered orally, once-daily and is the first in a class of medicines called Bruton's tyrosine kinase (BTK) inhibitors. Data suggest ibrutinib covalently bonds to BTK in malignant B cells, shutting down major proliferation and survival pathways. Ibrutinib is being developed by Janssen with Pharmacyclics, Inc. for the treatment of several forms of blood cancer. If approved, ibrutinib will be the first commercially available therapy targeting BTK.
"The EMA Marketing Authorisation Application is an important milestone in the development of ibrutinib," said Jane Griffiths, Group Company Chairman of Janssen Europe, the Middle East and Africa (EMEA). "At Janssen, we are dedicated to developing solutions that prolong and improve the lives of patients. If approved, ibrutinib will address a great unmet need for patients with CLL/SLL and MCL who have previously failed or become resistant to previous treatment."
The EMA filings follow the New Drug Application submission of ibrutinib to the U.S. Food and Drug Administration which was announced on 10 July 2013, for its use in the treatment of previously treated patients with CLL/SLL or MCL.
CLL/SLL and MCL belong to a group of blood cancers, known as B-cell malignancies, originating from B cells, a type of white blood cell (lymphocyte). CLL/SLL and MCL, are complex diseases that can be challenging to treat. As a result, many patients will relapse after a specific treatment and may require multiple treatments over the course of their disease.
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