AbbVie and Johnson & Johnson Announce Plan to Voluntarily Withdraw Two U.S. Indications for Ibrutinib (Imbruvica)

On April 6, AbbVie/Johnson & Johnson jointly announced plans to voluntarily withdraw the accelerated approvals of two indications for ibrutinib (Imbruvica) in the United States: for patients with mantle cell lymphoma (MCL) who have received at least one prior treatment, and for patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 therapy.

Ibrutinib's other approved indications in the United States are not affected. This voluntary action is due to requirements related to the FDA's accelerated approval for MCL and MZL. These indications were approved based on the overall response rate (ORR) from Phase II clinical studies. To confirm the clinical benefit of ibrutinib after accelerated approval, the FDA requires additional studies.

AbbVie/Johnson & Johnson have conducted two corresponding confirmatory studies: the Phase III SHINE study (NCT01776840) for previously untreated MCL patients and the Phase III SELENE study (NCT01974440) for relapsed or refractory MZL.

The SHINE study met its primary endpoint of progression-free survival (PFS) but did not demonstrate an overall survival (OS) benefit, and compared with the placebo group, ibrutinib also increased adverse reactions. Another SELENE study did not meet the primary endpoint of PFS.

AbbVie/Johnson & Johnson stated that the clinical profile of ibrutinib in its other approved indications remains unchanged, and the drug continues to be the most extensively studied and most prescribed oncology therapy in its class. They expressed full support for the FDA's accelerated approval process and are working with the FDA to complete the withdrawal of these indications.

"We sought accelerated approval in the U.S. for MCL and MZL indications of ibrutinib to provide a treatment option for patients with limited therapeutic choices at that time," said Roopal Thakkar, M.D., Senior Vice President and Chief Medical Officer of AbbVie. "While we are disappointed in the results of our confirmatory studies for these indications, we remain confident in the benefit/risk profile of ibrutinib across various forms of blood cancer globally."

Previously, ibrutinib also faced the withdrawal of a new indication's marketing application. In January 2023, the European Medicines Agency announced that Johnson & Johnson had withdrawn, on December 13, 2022, the new indication marketing application for ibrutinib in combination with bendamustine and rituximab for frontline treatment of MCL patients who are ineligible for autologous stem cell transplantation (ASCT).

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