Ibrutinib in combo with obinutuzumab for CLL/SLLMarch 7, 2019
AbbVie announced that the US FDA approved the use of ibrutinib (Imbruvica) in combination with obinutuzumab (Gazyva) for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
The new approval expands the use of ibrutinib which can already be administered as a single agent or in combination with bendamustine and rituximab (BR) for adult CLL/SLL patients.
Ibrutinib is a once-daily Bruton’s tyrosine kinase (BTK) inhibitor that is administered orally.
The FDA approval is based on results from the phase 3 iLLUMINATE (PCYC-1130) study, which showed the combination of ibrutinib 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 ibrutinib arm experienced a 77 percent reduction in risk of progression or death compared to the chlorambucil plus obinutuzumab arm. The chemotherapy-free, anti-CD20 combination regimen also showed an 85 percent reduction in risk of progression or death compared to chlorambucil plus obinutuzumab when evaluating PFS in patients with high-risk disease (17p deletion/TP53 mutation, 11q deletion, or unmutated IGHV).
The FDA also updated the ibrutinib label to include additional long-term efficacy follow-up supporting its use as a single agent in CLL/SLL from the Phase 3 RESONATE (PCYC-1112) and RESONATE-2 (PCYC-1115, PCYC-1116) international studies.
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 ibrutinib in combination with rituximab or obinutuzumab, consider administering ibrutinib prior to rituximab or obinutuzumab when given on the same day.