Update on AbbVie Withdrawal of Accelerated Approvals for Mantle Cell Lymphoma and Marginal Zone Lymphoma Indications

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On April 6, 2023, AbbVie announced its intent to withdraw the accelerated approval of ibrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy and with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy. Other approved indications for ibrutinib in the U.S. are not affected.

The Lymphoma Research Foundation (LRF) understands this news may be concerning to patients who use this medication or who have been considering it as a treatment option. Patients being treated with ibrutinib who have questions should consult a member of their healthcare team or contact the LRF Helpline at helpline@lymphoma.org or 800-500-9976 for additional information.

About Ibrutinib:

Ibrutinib is an FDA-approved bruton tyrosine kinase (BTK) inhibitor that is used to treat certain types of lymphoma. BTK is a protein critical for the growth and survival of B-cells.  BTK inhibitors can destroy malignant B-cells but leave healthy T-cells largely unaffected, which distinguishes them from several other treatment methods.