AbbVie, a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved the use of IMBRUVICA® (ibrutinib) in combination with obinutuzumab (GAZYVA®) for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The latest FDA approval expands the use of IMBRUVICA, which can already be administered as a single agent or in combination with bendamustine and rituximab (BR) for adult CLL/SLL patients.1 IMBRUVICA is a once-daily, first-in-class Bruton’s tyrosine kinase (BTK) inhibitor that is administered orally, and is jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc.
This latest IMBRUVICA FDA approval gives the healthcare community the first chemotherapy-free, anti-CD20 combination to treat CLL and SLL patients who have not yet started therapy. Also, and importantly, this new treatment combination helps reduce the need for chemotherapy
said Carol Moreno, M.D., Ph.D., Consultant Hematologist, Hospital de la Santa Creu Sant Pau, Autonomous University of Barcelona, Barcelona, Spain, and lead investigator of the iLLUMINATE study.
The FDA approval is based on results from the Phase 3 iLLUMINATE (PCYC-1130) study, which showed the combination of IMBRUVICA plus obinutuzumab significantly improved progression-free survival (PFS) compared to chlorambucil plus obinutuzumab in previously untreated CLL/SLL patients who were 65 years or older, or less than 65 years old with coexisting conditions. Patients treated in the IMBRUVICA arm experienced a 77 percent reduction in risk of progression or death compared to the chlorambucil plus obinutuzumab arm (hazard ratio [HR] 0.23; 95% confidence interval [CI]: 0.15-0.37; P<0.0001). The chemotherapy-free, anti-CD20 combination regimen also showed an 85 percent reduction in risk of progression or death compared to chlorambucil plus obinutuzumab (HR 0.15; 95% CI: 0.09-0.27) when evaluating PFS in patients with high-risk disease (17p deletion/TP53 mutation, 11q deletion, or unmutated IGHV). The data were recently presented in an oral session at the 2018 American Society of Hematology (ASH) Annual Meeting and simultaneously published in The Lancet Oncology.
We are living in a time of significant advances in cancer treatment, particularly in blood cancers, and this latest IMBRUVICA FDA approval is an example. I am proud that we can now give physicians and patients a new option to treat CLL and SLL without the need for chemotherapy,
said Danelle James, M.D., M.A.S., Head of Clinical Science, Pharmacyclics LLC, an AbbVie company.
The FDA also updated the IMBRUVICA label to include additional long-term efficacy follow-up supporting its use as a single agent in CLL/SLL from the Phase 3 RESONATETM (PCYC-1112) and RESONATETM-2 (PCYC-1115, PCYC-1116) international studies.
Warnings and Precautions include: hemorrhage, infections, cytopenias, cardiac arrhythmias, hypertension, second primary malignancies, tumor lysis syndrome, and embryo-fetal toxicity. The most common adverse reactions (occurring in 20% or more of patients) of all grades in patients treated with IMBRUVICA plus obinutuzumab in the iLLUMINATE study were neutropenia (48%), thrombocytopenia (36%), rash (36%), diarrhea (34%), musculoskeletal pain (33%), bruising (32%), cough (27%), infusion related reaction (25%), hemorrhage (25%), and arthralgia (22%).
The recommended dose of IMBRUVICA for CLL/SLL is 420 mg orally once daily until disease progression or unacceptable toxicity as a single agent or in combination with obinutuzumab, or BR. When administering IMBRUVICA in combination with rituximab or obinutuzumab, consider administering IMBRUVICA prior to rituximab or obinutuzumab when given on the same day.