Johnson & Johnson subsidiary Janssen-Cilag (Janssen) has filed a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for the approval of once daily oral drug ibrutinib for the treatment of two forms of blood cancer.
Ibrutinib, which is the first in a class of medicines called Bruton’s tyrosine kinase (BTK) inhibitors, is intended to treat adult patients with relapsed or refractory chronic lymphocytic leukaemia (CLL)/small lymphocytic leukaemia (SLL) and relapsed or refractory mantle cell lymphoma (MCL).
According to the data, ibrutinib binds irreversibly to the active site of Btk in malignant B cells, shutting down major proliferation and survival pathways.
If approved, Ibrutinib will become the first commercially available therapy targeting BTK, which is an important protein involved in mediating the cellular signalling pathways which control B cell maturation and survival.
Janssen Europe, the Middle East and Africa (EMEA) group company chairman Jane Griffiths said the EMA marketing authorisation application is a major milestone in the development of ibrutinib.
"At Janssen, we are dedicated to developing solutions that prolong and improve the lives of patients," Grifiths said.
"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 submission follows the New Drug Application (NDA) filing of ibrutinib to the US Food and Drug Administration (FDA) in July, to use the drug for treatment of previously treated patients with CLL/SLL or MCL.
Jointly developed by Pharmacyclics and Janssen, Ibrutinib is an orally bio-available small-molecule inhibitor of BTK with antineoplastic activity.
BTK is a key mediator of at least three critical B-cell pro-survival mechanisms occurring in parallel: regulation of apoptosis, adhesion, and cell migration and homing.
The effectiveness of ibrutinib alone or in combination with other treatments is being studied in several B-cell malignancies, including, Waldenstrom’s macroglobulinemia, multiple myeloma, CLL/SLL, MCL, diffuse large B-cell lymphoma and follicular lymphoma.
CLL/SLL and MCL belong to a group of blood cancers, called B-cell malignancies, originating from B cells, a type of white blood cell (lymphocyte). They are complex diseases that can be challenging to treat.
Image: Lymph node with mantle cell lymphoma. Photo: courtesy of Gabriel Caponetti.