Posted by Michael Wonder on 28 Jun 2022
Janssen receives positive CHMP opinion for Imbruvica (ibrutinib) in a fixed-duration combination regimen for adult patients with previously untreated chronic lymphocytic leukaemia
24 June 2022 - The positive opinion is based on Phase 3 GLOW and Phase 2 CAPTIVATE study results, which investigated the efficacy and safety of ibrutinib plus venetoclax in patients with previously untreated chronic lymphocytic leukaemia.
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the CHMP of the EMA has issued a positive opinion recommending approval of a new treatment option with Imbruvica (ibrutinib) in an oral fixed-duration combination with venetoclax for adults with previously untreated chronic lymphocytic leukaemia.
