FDA approves Imbruvica + Gazyva combination to treat untreated chronic lymphocytic leukemia/small lymphocytic lymphoma . Abbvie + Janssen Biotech

AbbVie BV announced that the 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. 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.

The FDA approval is based on results from the Phase III 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.>

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 III RESONATETM (PCYC-1112) and RESONATETM-2 (PCYC-1115, PCYC-1116) international studies.