Data from Pharmawand - Curated by EPG Health - Date added 10 November 2019
AbbVie announced it has submitted a supplemental New Drug Application (sNDA) to the FDA for Imbruvica (ibrutinib) in combination with rituximab for the first-line treatment of younger patients (70 years old or younger) with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
The submission is based on results from the Phase III E1912 study – designed and conducted by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health. The study showed significantly improved progression-free survival (PFS) and overall survival (OS) in patients treated with Imbruvica plus rituximab, compared to those treated with fludarabine, cyclophosphamide and rituximab (FCR). Safety data were consistent with the known safety profile of Imbruvica.
The application is being reviewed under the Real-Time Oncology Review (RTOR) pilot program, which allows the 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.
Comment: :The sNDA is based on findings from the phase III E 1912 trial, in which the combination demonstrated an 83% reduction in the risk of death compared with standard fludarabine, cyclophosphamide, and rituximab (FCR) after a median follow-up of 33.6 months (HR, 0.17; 95% CI, 0.05-0.54; P <.001)2,3 Additionally, there was a 65% reduction in the risk of progression or death with Ibrutinib/rituximab versus FCR (HR, 0.35; 95% CI, 0.22-0.56; P <.001). Moreover, safety data were consistent with the known tolerability of ibrutinib. Four-year follow-up findings of the phase III trial will be presented at the 2019 ASH Annual Meeting, AbbVie, which jointly develops ibrutinib with Janssen Biotech, Inc., stated in a press release.