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FDA approves Imbruvica for first-line CLL treatment
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The FDA expanded the approval of ibrutinib to include first-line treatment of patients with chronic lymphocytic leukemia.
Ibrutinib (Imbruvica; Pharmacyclics, Janssen), an oral Bruton’s tyrosine kinase inhibitor, now is approved to treat all patients with CLL regardless of treatment history. It also is approved for patients with previously treated mantle cell lymphoma, as well as patients with Waldenstrom’s macroglobulinemia.
“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,” Michael Severino, MD, executive vice president for research and development and chief scientific officer at AbbVie, parent company of Pharmacyclics, said in a press release. “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 FDA based the frontline CLL indication on results of RESONATE-2, a randomized, open-label phase 3 trial designed to compare ibrutinib vs. chlorambucil in 269 patients with treatment-naive CLL or small lymphocytic lymphoma aged 65 years or older.
PFS served as the primary endpoint.
The results — presented in December at the ASH Annual Meeting and Exposition and simultaneously published in The New England Journal of Medicine — showed ibrutinib-treated patients experienced longer median PFS (not reached vs. 18.9 months). This translated into an 84% reduction in risk for progression or death (HR = 0.16; 95% CI, .09-0.28).
“The progression-free survival data seen in these previously untreated CLL patients are strong and encouraging,” Jan Burger, MD, PhD, associate professor in the department of leukemia at The University of Texas MD Anderson Cancer Center and a lead investigator on RESONATE-2, said in the press release. “This is especially important for first-line CLL patients, when considering the safety profile. This treatment represents another option for these patients.”
RESONATE-2 results showed ibrutinib also significantly increased 24-month survival (98% vs. 85%; HR = 0.16; P < .001) and overall response rate (82.4% vs. 35.3%; P < .0001).
The most common adverse events reported in ibrutinib-treated patients were diarrhea, fatigue, cough and nausea. Researchers reported four incidences of grade 3 hemorrhage and one grade 4 hemorrhage in the ibrutinib arm.