Johnson & Johnson's Janssen : CHMP Backs Expanded Imbruvica Use in Chronic Lymphocytic Leukemia

By Colin Kellaher

Johnson & Johnson's Janssen Pharmaceutical Cos. unit on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended expanded approval of the blockbuster blood-cancer drug Imbruvica in certain patients with chronic lymphocytic leukemia.

Janssen, which jointly develops and markets Imbruvica with AbbVie Inc., said the recommendation covers the drug in an oral fixed-duration combination with venetoclax for adults with previously untreated chronic lymphocytic leukemia, a type of cancer that starts from white blood cells in the bone marrow.

Janssen said the combination, if approved, would be the first all-oral, once daily, fixed-duration combination regimen for first-line treatment of the disease. The European Commission, which generally follows the CHMP's advice, will make a final decision on approval.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

06-24-22 0836ET