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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 17 October 2018, the U.S. Food and Drug Administration (FDA) accepted the Supplemental New Drug Application (sNDA) and granted priority review to ibrutinib (Imbruvica®), Bruton's tyrosine kinase (BTK) inhibitor, in combination with obinutuzumab (Gazyva®) in previously untreated adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL).
The submission of a sNDA was based on results from the phase III, multi-center, randomized iLLUMINATE (PCYC-1130) trial (NCT02264574), which demonstrated that ibrutinib plus obinutuzumab was associated with statistically significantly longer progression-free survival versus chlorambucil plus obinutuzumab, in adults with previously untreated CLL/SLL, as assessed by an independent review committee.
According to the drug manufacturers, AbbVie, “if the sNDA is approved, the use of Imbruvica® with obinutuzumab could become the first chemotherapy-free, anti-CD20 combination approved by the FDA for the first-line treatment of CLL/SLL.”
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