Janssen-Cilag (Janssen), a subsidiary of Johnson & Johnson pharmaceutical firm, has submitted marketing authorization 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.
The approval is intended to treat adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) and or relapsed or refractory mantle cell lymphoma (MCL).
The company claims that ibrutinib is the first in a class of medicines called Bruton's tyrosine kinase (BTK) inhibitors.
According to the company, ibrutinib covalently bonds to BTK in malignant B cells, shutting down major proliferation and survival pathways.
If the company receives EMA approval, the drug being developed in collaboration with Pharmacyclics will be the first commercially available therapy targeting BTK, an important protein involved in mediating the cellular signalling pathways which control B cell maturation and survival.
The MAA to EMA follows the New Drug Application (NDA) filing of ibrutinib to the US Food and Drug Administration (FDA) in July 2013, to use the drug for treatment of previously treated patients with CLL/SLL or MCL.
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) and they are complex diseases that can be challenging to treat.
