Imbruvica (ibrutinib) approved by FDA for the first-line treatment of chronic lymphocytic leukemia

First FDA-approved chemotherapy-free treatment option for first-line CLL patients.

"This approval represents a significant leap forward for patients diagnosed with CLL who may want to consider an alternative first-line treatment to traditional chemotherapy," said Michael Severino, executive vice president, research and development and chief scientific officer, AbbVie. "AbbVie is committed to making significant improvements in the lives of patients with hematologic malignancies and will continue to explore ways to improve treatment options for patients."

The National Comprehensive Cancer Network (NCCN) recently published an update to its clinical practice guidelines for non-Hodgkin's lymphomas, granting Imbruvica a category 1 recommendation for certain CLL patients, the highest recommendation assigned by the organization. Specifically, NCCN recommends Imbruvica as a first-line treatment option for frail CLL patients with significant comorbidities, as well as for CLL patients with or without del 17p or the genetic mutation TP53 who are 70 years or older, or younger patients with significant comorbidities. The NCCN guidelines inform prescribing and reimbursement practices in many institutions in the US and internationally.

"The progression-free survival data seen in these previously untreated CLL patients are strong and encouraging," said Dr. Jan Burger, Associate Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX and the RESONATE-2 lead study investigator. "This is especially important for first-line CLL patients, when considering the safety profile. This treatment represents another option for these patients."

Imbruvica is now approved to treat CLL patients regardless of their treatment history (treatment-naïve and previously-treated patients). In addition, Imbruvica is approved to treat high-risk CLL patients with del 17p,1 a genetic aberration that occurs when part of chromosome 17, the location of the tumour suppressor gene p53, has been lost or deleted.

Imbruvica significantly prolonged progression-free survival (PFS; primary endpoint) as determined by an Independent Review Committee (IRC), reducing the risk of progression or death by 84% versus chlorambucil (hazard ratio [HR], 0.161 [95% confidence interval: 0.091, 0.283]; median PFS: not reached for Imbruvica vs. 18.9 months [95% confidence interval: 14.1, 22.0] for chlorambucil). Imbruvica was also associated with a significantly higher IRC-assessed overall response rate (ORR: a composite of complete and partial responses; 82.4% vs. 35.3%; P<0.0001) versus chlorambucil. Five patients (3.7%) in the Imbruvica arm achieved a complete response, compared to two patients (1.5%) in the chlorambucil arm.