Posted by Michael Wonder on 04 Dec 2021
Janssen seeks approval of Imbruvica (ibrutinib) in a fixed duration regimen for patients with untreated chronic lymphocytic leukaemia
30 November 2021 - Application based on Phase 3 GLOW and Phase 2 CAPTIVATE study results, which investigated the safety and efficacy of an all oral fixed-duration ibrutinib plus venetoclax combination regimen in adult patients with previously untreated chronic lymphocytic leukaemia.
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II variation application to the EMA seeking approval of a new treatment option for Imbruvica (ibrutinib) as a fixed duration combination with venetoclax for adult patients with previously untreated chronic lymphocytic leukaemia.
