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The Food and Drug Administration has approved ibrutinib (Imbruvica) for use in combination with obinutuzumab to treat adults with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
This is the tenth FDA approval for ibrutinib, a Bruton tyrosine kinase inhibitor jointly developed and commercialized by Pharmacyclics, an AbbVie company, and Janssen Biotech.
The approval is supported by the phase 3 iLLUMINATE trial (NCT02264574).
Results from this study were recently presented at the annual meeting of the American Society of Hematology (Blood. 2018;132:691) and published in the Lancet Oncology (2019 Jan;20[1]:43-56).
The iLLUMINATE trial enrolled newly diagnosed CLL patients who were randomized to receive ibrutinib plus obinutuzumab (n = 113) or chlorambucil plus obinutuzumab (n = 116).
The median follow-up was 31.3 months. The overall response rate was 88% in the ibrutinib arm and 73% in the chlorambucil arm. The complete response rate, including complete response with incomplete marrow recovery, was 19% and 8%, respectively.
The median progression-free survival was not reached in the ibrutinib arm and was 19.0 months in the chlorambucil arm (hazard ratio, 0.23; 95% confidence interval, 0.15-0.37; P less than .0001). The estimated 30-month progression-free survival was 79% and 31%, respectively.
The most common grade 3/4 adverse events in both arms were neutropenia (36% in the ibrutinib arm and 46% in the chlorambucil arm) and thrombocytopenia (19% and 10%, respectively).
There were 10 deaths caused by adverse events in the ibrutinib arm and 3 in the chlorambucil arm. One death was considered possibly related to ibrutinib (sudden death), and another was considered possibly related to chlorambucil (neuroendocrine carcinoma of the skin).
The Food and Drug Administration has approved ibrutinib (Imbruvica) for use in combination with obinutuzumab to treat adults with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
This is the tenth FDA approval for ibrutinib, a Bruton tyrosine kinase inhibitor jointly developed and commercialized by Pharmacyclics, an AbbVie company, and Janssen Biotech.
The approval is supported by the phase 3 iLLUMINATE trial (NCT02264574).
Results from this study were recently presented at the annual meeting of the American Society of Hematology (Blood. 2018;132:691) and published in the Lancet Oncology (2019 Jan;20[1]:43-56).
The iLLUMINATE trial enrolled newly diagnosed CLL patients who were randomized to receive ibrutinib plus obinutuzumab (n = 113) or chlorambucil plus obinutuzumab (n = 116).
The median follow-up was 31.3 months. The overall response rate was 88% in the ibrutinib arm and 73% in the chlorambucil arm. The complete response rate, including complete response with incomplete marrow recovery, was 19% and 8%, respectively.
The median progression-free survival was not reached in the ibrutinib arm and was 19.0 months in the chlorambucil arm (hazard ratio, 0.23; 95% confidence interval, 0.15-0.37; P less than .0001). The estimated 30-month progression-free survival was 79% and 31%, respectively.
The most common grade 3/4 adverse events in both arms were neutropenia (36% in the ibrutinib arm and 46% in the chlorambucil arm) and thrombocytopenia (19% and 10%, respectively).
There were 10 deaths caused by adverse events in the ibrutinib arm and 3 in the chlorambucil arm. One death was considered possibly related to ibrutinib (sudden death), and another was considered possibly related to chlorambucil (neuroendocrine carcinoma of the skin).
The Food and Drug Administration has approved ibrutinib (Imbruvica) for use in combination with obinutuzumab to treat adults with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
This is the tenth FDA approval for ibrutinib, a Bruton tyrosine kinase inhibitor jointly developed and commercialized by Pharmacyclics, an AbbVie company, and Janssen Biotech.
The approval is supported by the phase 3 iLLUMINATE trial (NCT02264574).
Results from this study were recently presented at the annual meeting of the American Society of Hematology (Blood. 2018;132:691) and published in the Lancet Oncology (2019 Jan;20[1]:43-56).
The iLLUMINATE trial enrolled newly diagnosed CLL patients who were randomized to receive ibrutinib plus obinutuzumab (n = 113) or chlorambucil plus obinutuzumab (n = 116).
The median follow-up was 31.3 months. The overall response rate was 88% in the ibrutinib arm and 73% in the chlorambucil arm. The complete response rate, including complete response with incomplete marrow recovery, was 19% and 8%, respectively.
The median progression-free survival was not reached in the ibrutinib arm and was 19.0 months in the chlorambucil arm (hazard ratio, 0.23; 95% confidence interval, 0.15-0.37; P less than .0001). The estimated 30-month progression-free survival was 79% and 31%, respectively.
The most common grade 3/4 adverse events in both arms were neutropenia (36% in the ibrutinib arm and 46% in the chlorambucil arm) and thrombocytopenia (19% and 10%, respectively).
There were 10 deaths caused by adverse events in the ibrutinib arm and 3 in the chlorambucil arm. One death was considered possibly related to ibrutinib (sudden death), and another was considered possibly related to chlorambucil (neuroendocrine carcinoma of the skin).