6 April 2023 - AbbVie announced today the intent to voluntarily withdraw, in the US, accelerated Imbruvica (ibrutinib) approvals for patients with the blood cancers mantle cell lymphoma who have received at least one prior therapy and with marginal zone lymphoma who require systemic therapy and have received at least one prior anti-CD20-based therapy.

This voluntary action is due to requirements related to the accelerated approval status granted by the US FDA for mantle cell lymphoma and marginal zone lymphoma. These indications were approved via this pathway based on overall response rates in Phase 2 clinical studies. To confirm clinical benefit following accelerated approvals, additional studies are required by the FDA.

Read AbbVie press release