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FDA Grants Priority Review to Ibrutinib Plus Obinutuzumab in Frontline CLL

Jason M. Broderick @jasoncology
Published: Wednesday, Oct 17, 2018

Danelle James, MD

Danelle James, MD

The FDA has granted a priority designation to a supplemental new drug application (sNDA) for ibrutinib (Imbruvica) for use in combination with obinutuzumab (Gazyva) for the frontline treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

The sNDA is based on data from the phase III iLLUMINATE (PCYC-1130) trial, which showed that frontline treatment with ibrutinib combined with obinutuzumab significantly improved progression-free survival (PFS) compared with chlorambucil plus obinutuzumab in patients with CLL/SLL. AbbVie (Pharmacyclics) and Janssen Biotech, the codevelopers of ibrutinib, reported in a press release that the data from the study will be shared at a future medical meeting.

Under the priority designation, the FDA will review the sNDA within 6 months from the acceptance of the filing, compared with the standard 10 months.

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