The U.S. Food and Drug Administration (FDA) has approved an expansion to the IMBRUVICA® (ibrutinib) U.S. Prescribing Information (PI) based on data supporting its use in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Janssen has announced. The approved label now includes overall survival (OS) data from the Phase 3 RESONATE™-2 (PCYC-1115) trial in treatment-naïve CLL/SLL patients 65 years or older. The updated label also contains clinical data from the Phase 3 HELIOS (CLL3001) trial investigating the use of IMBRUVICA in combination with bendamustine and rituximab (BR) versus placebo plus BR in patients with relapsed or refractory CLL/SLL.
About the IMBRUVICA Label Update
Updated data from the RESONATE-2 trial reflect a statistically significant 56 percent reduction in the risk of death with IMBRUVICA compared to chlorambucil after a median follow-up of 28.1 months (HR=0.44 [95 percent CI, 0.21, 0.92]). The RESONATE-2 trial served as the basis for the March 2016 FDA approval of IMBRUVICA as a first-line treatment for patients with CLL.
Additionally, the first data from the HELIOS study on the use of IMBRUVICA in combination with other therapies were added to the label, highlighting the improvement in progression-free survival (PFS) and overall response rate (ORR) when using IMBRUVICA plus BR versus placebo plus BR in patients with relapsed/refractory CLL/SLL. Following a review of the November 2015 supplemental New Drug Application, the FDA has expanded the indication to include the use of IMBRUVICA for SLL patients with or without deletion of the chromosome 17p (del 17p). SLL is a slow-growing lymphoma that is similar to CLL.1,2
"The clinical development plan for IMBRUVICA is very robust and includes many Phase 2 and 3 clinical trials across various indications and combinations," said Peter F. Lebowitz, M.D., Ph.D., Global Oncology Head, Janssen Research & Development, LLC. "In partnership with Pharmacyclics, an AbbVie company, we continue to explore the clinical utility of IMBRUVICA and potential benefit it offers to patients with CLL/SLL and other hematologic malignancies."
"The update helps to affirm the established efficacy, safety and tolerability of this therapy for the treatment of patients with CLL/SLL, both as a monotherapy or in combination with other agents," said Jan Burger, M.D., Ph.D., Associate Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX and RESONATE-2 study lead investigator. "It reflects the growing body of clinical evidence supporting this therapy as a potential treatment option for people living with CLL/SLL."