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This marks ibrutinib's 11th FDA approval.
The US Food and Drug Administration (FDA) today approved ibrutinib (IMBRUVICA) in combination with rituximab to treat chronic lymphocytic leukemia or small lymphocytic lymphoma in previously untreated patients.
The approval marks ibrutinib’s 11th such indication since its initial approval in 2013.
“The gold-standard first-line treatment option for many patients with chronic lymphocytic leukemia who were fit enough to tolerate an aggressive treatment course had been the intravenous chemoimmunotherapy of FCR—that is, until today,” Brian Koffman, MD, CM, said in a statement.
The approval came after positive results from the phase 3 E1912 study, which was designed and conducted by the ECOG-ACRIN Cancer Research Group with sponsorship from the National Cancer Institute.
Findings of the study showed that previously untreated patients who were <70 years old with chronic lymphocytic leukemia—a rare form of blood and bone marrow cancer—lived longer without disease progression with ibrutinib plus rituximab compared to those with a potent chemoimmunotherapy regimen of fludarabine, cyclophosphamide and rituximab (FCR).
At 37 months follow-up, ibrutinib plus rituximab significantly improved progression-free survival compared to FCR (HR, .34; 95% CI, .22-.52; P <.0001). At 49 months follow-up, median survival was not reached with a total of 23 deaths: 11 (3%) in the ibrutinib plus rituximab group and 12 (7%) in the FCR treatment cohort.
“The results from ECOG-ACRIN's E1912 clinical trial in previously untreated, younger adult patients and today's milestone represent a paradigm shift in how physicians can treat patients with (chronic lymphocytic leukemia) and may enable many to choose a non-chemotherapy treatment option,” Koffman, chief medical officer and executive vice president of CLL Society, said.
Common adverse reactions, which occurred in >30% of patients included fatigue (80% vs 78% in FCR); musculoskeletal pain (61% vs 35%); diarrhea (53% vs 27%); rash (49% vs 29%); and hypertension (42% vs 22%), among others.
The recommended dose for chronic lymphocytic leukemia or small lymphocytic lymphoma is 420 mg orally once a day.