Ibrutinib changed everything on November 23, 2013, when, based on encouraging early research, it received FDA’s accelerated approval for the rare blood cancer, mantle cell lymphoma (MCL), a B-cell lymphoma closely related to chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
Multiple other approvals have followed in the last decade, including accelerated approval for marginal zone lymphoma (MZL) and full approval for CLL/SLL.
As the link below explains, the results from the larger confirmatory (registration) phase 3 trials (for more on trial phases, click on Trial Phases) required for full approval were not adequate to move forward to seek full FDA approval. As a result, on April 6, 2023, AbbVie announced its intent to voluntarily withdraw accelerated ibrutinib approvals for patients with mantle cell lymphoma and marginal zone lymphoma in the U.S.
This does not affect its use in CLL/SLL and other approved indications. No new drug-related problems were discovered. And it only applies to the U.S.
Here is the link to the official AbbVie press release: Update on IMBRUVICA® (ibrutinib) U.S. Accelerated Approvals for Mantle Cell Lymphoma and Marginal Zone Lymphoma Indications.
CLL Society strongly supports the need for early access to new therapies through accelerated approval but also the need for more extended confirmatory studies.