Research & Development
US FDA supplemental New Drug Application submitted for AbbVie's IMBRUVICA in combination with rituximab
12 November 2019 -

Research-based global biopharmaceutical company AbbVie (NYSE: ABBV) announced yesterday that it has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for IMBRUVICA (ibrutinib) in combination with rituximab for the first-line treatment of younger patients (70 years old or younger) with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).

The submission is based on results from the Phase three E1912 study that was designed and conducted by the ECOG-ACRIN Cancer Research Group and sponsored by the National Cancer Institute, part of the National Institutes of Health. The study indicated significantly improved progression-free survival and overall survival in patients treated with IMBRUVICA plus rituximab, compared to those treated with fludarabine, cyclophosphamide and rituximab. Safety data were consistent with the known safety profile of IMBRUVICA.

The application is being reviewed under the Real-Time Oncology Review pilot program that enables the US FDA to review data before the applicant formally submits the complete application. The program is designed to explore a more efficient review process to ensure safe and effective treatments become available to patients earlier, while maintaining quality of review.

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