Update on Withdrawal of Ibrutinib Accelerated Approvals for MCL and MZL in the United States

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AbbVie announced that it intends to voluntarily withdraw, in the United States, accelerated ibrutinib (Imbruvica) approvals for patients with mantle cell lymphoma (MCL) who have received at least one prior therapy as well as patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti–CD20–based therapy. The company clarified that other approved indications for ibrutinib in the United States are not affected.


The voluntary withdrawal was the result of requirements related to the accelerated approval status granted by the U.S. Food and Drug Administration for patients with MCL and MZL. These indications were approved via this pathway based on overall response rates in recent phase II trials. Following accelerated approvals, the FDA required additional studies to confirm the clinical benefits of ibrutinib.

The phase III SHINE study ( identifier NCT01776840) in patients with previously untreated MCL and the phase III SELENE study (NCT01974440) in patients with relapsed or refractory MZL served as confirmatory studies.

The SHINE study met its primary endpoint of progression-free survival. Patients who received the addition of ibrutinib to chemoimmunotherapy experienced increased adverse reactions compared with those who took placebo. The findings of the SHINE study were published by Wang et al in The New England Journal of Medicine and simultaneously presented at the 2022 ASCO Annual Meeting.  

The SELENE study did not meet its primary endpoint of progression-free survival, and the findings will be presented at a future scientific forum.


Ibrutinib’s established clinical profile in other approved indications will remain unchanged. AbbVie described the medication as the most comprehensively studied and prescribed cancer treatment in its class and emphasized that it will continue to be an important therapy for patients and health-care professionals around the world.

“We pursued accelerated approvals for MCL and MZL indications for [ibrutinib] in the [United States] to offer a treatment to patients who, at the time, had limited therapeutic options. While we are disappointed in the outcome of the confirmatory trials for these indications, we remain confident in the benefit/risk profile of [ibrutinib] for patients living with multiple forms of [hematologic malignancies] around the world,” said Roopal Thakkar, MD, Senior Vice President of Development and Regulatory Affairs and Chief Medical Officer at AbbVie.

AbbVie further stated that the company fully supports the FDA’s accelerated approval process and is working with the FDA to complete the withdrawals. Health-care professionals in the United States should consider the withdrawal of these indications in their treatment plans for patients with MCL and MZL currently taking ibrutinib. AbbVie concluded that they are committed to supporting patients who are currently benefiting from ibrutinib therapy.


The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.