Janssen-Cilag submits EMA Marketing Authorization for ibrutinib

US health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen-Cilag International has submitted a Marketing Authorization Application to the European Medicines Agency 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 USA-based Pharmacyclics (Nasdaq: PCYC), in a deal that involved $150 million upfront and further potential payments of $825 million. If approved, ibrutinib will be the first commercially available therapy targeting BTK.

Could address an unmet need