FDA approves Imbruvica plus rituximab for newly diagnosed CLL
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The FDA approved ibrutinib in combination with rituximab for treatment of newly diagnosed patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.
The agency based the approval of the ibrutinib (Imbruvica; Janssen, Pharmacyclics) and rituximab (Rituxan; Genentech, Biogen) combination on results of the phase 3 E1912 study, which included 529 patients aged 70 years or younger (median age, 58 years) with untreated CLL.
Researchers randomly assigned 354 patients to ibrutinib plus rituximab. The other 175 patients received standard chemoimmunotherapy with fludarabine, cyclophosphamide and rituximab (FCR).
After median follow-up of 37 months, a higher percentage of those treated with ibrutinib plus rituximab remained progression free (88% vs. 75%; HR = 0.34; 95% CI, 0.22-0.52).
After median follow-up of 49 months, median OS had not been reached in the ibrutinib-rituximab group and was 7% in the FCR group.
“FCR, a chemoimmunotherapy-based regimen, has been the standard of care for many previously untreated younger patients with CLL. With the introduction of this ibrutinib-rituximab combination, patients now have a more effective, nonchemoimmunotherapy option,” Brian Koffman, MD, CM (retired), co-founder and chief medical officer/executive vice president of the nonprofit CLL Society, said in a press release. “In the 14 years since I was first diagnosed with CLL, the treatment landscape has advanced dramatically for the better, with ibrutinib continuing to play a pioneering role in defining what it means to live with this disease."
The FDA granted the approval through its Real-Time Oncology Review pilot program.