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FDA accepts Supplemental New Drug Application and grants Priority Review status to ibrutinib in combination with obinutuzumab  for the treatment of previously untreated chronic lymphocytic leukemia

Oct 18, 2018

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 versuschlorambucil 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.” 

  1. PR Newswire: AbbVie Announces Supplemental New Drug Application Accepted for Priority Review by U.S. FDA for IMBRUVICA® (ibrutinib) in Combination with Obinutuzumab (GAZYVA®) for Previously Untreated Chronic Lymphocytic Leukemia (CLL). 2018 Oct 17.[Accessed 2018 Oct 17].