Ibrutinib voluntarily withdrawn in U.S. for lymphoma indications

On April 6, 2023, it was announced that ibrutinib, a Bruton’s tyrosine kinase inhibitor, has been voluntarily withdrawn in the United States for the treatment of patients with mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL).¹ This follows a recommendation from the U.S. Food and Drug Administration (FDA).

Following two phase II trials, ibrutinib initially received accelerated approval due to its positive overall response rates. Continued approval was dependent upon its clinical benefit being demonstrated in the confirmatory phase III SHINE study (NCT01776840), which focused on patients with previously untreated MCL, and the phase III SELENE study (NCT01974440), which focused on patients with relapsed/refractory MZL and follicular lymphoma. As part of the FDA recommendation, it was outlined that primary endpoints from the two confirmatory studies were insufficient to support a full approval.