Janssen and AbbVie announced they would withdraw mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL) applications in the US.
Janssen and AbbVie announced that they would withdraw the applications of Imbruvica (ibrutinib) for mantle cell lymphoma and marginal zone lymphoma. The applications will be withdrawn for MCL patients who have received one prior therapy and for those with MZL previously treated with at least one anti-CD20 therapy.
The continued approval for Imbruvica was based on the results of Phase 3 confirmatory studies, including the SHINE study for patients previously treated with MCL and the SELENE study for patients with relapsed or refractory follicular lymphoma or MZL. The FDA advised that the primary endpoint improvements were insufficient for full approval.
However, Imbruvica did meet the primary endpoint of demonstrating improvements in progression-free survival in the Phase 3 SHINE study for patients with untreated MCL.
Imbruvica is an oral, once-daily therapy that blocks Bruton’s tyrosine kinase (BTK) protein.