AbbVie announced that the Food and Drug Administration (FDA) has approved Imbruvica (ibrutinib; Pharmacyclics and Janssen Biotech ) as a first-line treatment for patients with chronic lymphocytic leukemia (CLL).

The FDA approval was based on data from the Phase 3 randomized, multicenter, open-label RESONATE-2 trial (n=269) that evaluated Imbruvica vs. chlorambucil in treatment-naive patients with CLL or small lymphocytic lymphoma (SLL) aged ≥65 years old.

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In the study, treatment with Imbruvica significantly prolonged progression-free survival (PFS) by reducing the risk of progression or death by 84% vs. chlorambucil (hazard ratio [HR] 0.161, 95% CI: 0.091, 0.283). Imbruvica was also associated with a significantly higher Independent Review Committee (IRC)-assessed overall response rate (82.4%) vs. chlorambucil (35.3%). A total of 5 patients achieved a complete response in the Imbruvica arm vs. 2 patients in the chlorambucil arm. 

The National Comprehensive Cancer Network (NCCN) updated its clinical practice guidelines for non-Hodgkin’s lymphomas, placing Imbruvica as a category 1 recommendation for certain CLL patients. Imbruvica is also recommended as first-line treatment 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 aged ≥70 years old, or younger patients with significant comorbidities. 

Imbruvica, a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, is now indicated for the treatment of CLL regardless of the patient’s treatment history. It is also approved to treat high-risk CLL patients with del 17p. It is available as 140mg strength capsules.

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