FDA Expands the Use of Ibrutinib to Include Combination for Certain Patients With CLL/SLL

JANUARY 28, 2019
The FDA has approved the use of ibrutinib (Imbruvica®, AbbVie) in combination with obinutuzumab (Gazyva®) for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). This approval expands the use of ibrutinib, which can also be administered as a single agent or in combination with bendamustine and rituximab (BR) for adult CLL/SLL patients. 

The approved ibrutinib therapy is a once-daily, first-in-class Bruton's tyrosine kinase (BTK) inhibitor that is administered orally. It 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 3 iLLUMINATE (PCYC-1130) study, according to AbbVie. The study 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 aged 65 years or older, or less than age 65 years old with coexisting conditions.

"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, MD, PhD., Consultant Hematologist, Hospital de la Santa Creu Sant Pau, Autonomous University of Barcelona, Barcelona, Spain, and lead investigator of the iLLUMINATE study, in a prepared statement.

Patients in the iLLUMINATE study who were treated in the ibrutinib arm experienced a 77% 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% 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 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.

For more information, visit our sister publication OncLive.com.


AbbVie Announces U.S. FDA Approval of IMBRUVICA® (ibrutinib) Plus Obinutuzumab (GAZYVA®) - First Chemotherapy-Free, Anti-CD20 Combination Regimen Approved for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) in Previously Untreated Patients [news release]. North Chicago, Illinois; January 28, 2019: AbbVie website. http://www.pharmacytimes.com/link/249. Accessed January 28, 2019.