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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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