AbbVie files sNDA for Imbruvica
US drug major AbbVie (NYSE: ABBV) submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration requesting a new indication for Imbruvica (ibrutinib).
The application is based on the randomized, multi-center, open-label Phase III RESONATE-2 (PCYC-1115) trial assessing the use of Imbruvica versus chlorambucil in treatment-naive chronic lymphocytic leukemia (CLL) patients aged 65 years or older.
AbbVie announced top-line findings from the trial in June 2015 showing that Imbruvica improved progression-free survival (PFS; primary endpoint) and multiple secondary endpoints including overall survival (OS) and overall response rate (ORR) in treatment-naive patients with CLL. Imbruvica is jointly developed and commercialized by Pharmacyclics, an AbbVie company, and Janssen Biotech, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ).
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