Posted by Michael Wonder on 11 Mar 2022
Janssen seeks approval of a new indication for Imbruvica (ibrutinib) for use in patients with untreated mantle cell lymphoma
8 March 2022 - Application based on Phase 3 SHINE study results, which investigated the safety and efficacy of all-oral ibrutinib in combination with bendamustine and rituximab in adult patients with previously untreated mantle cell lymphoma
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 indication for Imbruvica (ibrutinib) in combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for autologous stem cell transplantation.
