EU - Janssen announced withdrawal of Imbruvica BR combo extension of indication for treatment of untreated MCL

Janssen has announced the withdrawal of its extension of indication application for Imbruvica (ibrutinib) in combination with bendamustine and rituximab (BR) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are unsuitable for autologous stem cell transplantation (ASCT).

This decision follows the CHMP feedback from an early evaluation that indicated the SHINE study (MCL3002) data are considered insufficient to support the approval for the use of ibrutinib in the proposed indication in the EU.

As a reminder, the SHINE study (MCL3002) is a randomized, double-blind, placebo-controlled phase 3 study of ibrutinib in combination with BR in subjects with newly diagnosed MCL. The CHMP had adopated several Request for Supplementary Information on 13.10.2022 and 23.06.2022.

Reference link: Janssen press release