Johnson & Johnson filed an application with the European Medicines Agency seeking approval of a combination of its drug Imbruvica and Roche Holding AG's Rituxan as a first-line treatment for a type of blood cancer.
The company's application is backed by data from a late-stage study that evaluated the combination therapy against the standard of care in 529 patients with previously untreated chronic lymphocytic leukemia.
CLL is a type of cancer that affects the white blood cells and occurs in the bone marrow.
Results from the study showed that the combination therapy proved to be better than a chemotherapy-based standard of care in extending the life-span of patients without the disease worsening.
North Chicago, Ill.-based AbbVie Inc. co-markets Imbruvica, or ibrutinib, in the U.S. with J&J's Janssen Pharmaceutical Ltd. The medication is currently approved for various blood cancer indications.