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An expert panel hosted by
Customizing first-line BTK inhibitors for CLL
with Gilles Salles, Paolo Ghia, and Francesc Bosch
Wednesday, October 23, 2024
18:30-19:30 BST
This independent educational activity is supported by Pharmacyclics LLC, an AbbVie Company and Janssen Biotech. All content is developed independently by the faculty. The funder is allowed no influence on the content of this activity.
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On April 6, 2023, it was announced that ibrutinib, a Bruton’s tyrosine kinase inhibitor, has been voluntarily withdrawn in the United States for the treatment of patients with mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL).1 This follows a recommendation from the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.
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