The new expanded approval was based on positive results from the phase 3 E1912 study.
Officials with the FDA have approved an expanded use of ibrutinib (Imbruvica, Janssen and Pharmacyclics) in combination with rituximab for the treatment of patients that have been newly diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma. For ibrutinib, this is the 11th FDA approval across 6 disease areas, and the 6th approval for treatment of CLL.1
The new expanded approval was based on positive results from the phase 3 E1912 study, which was presented at the American Society of Hematology (ASH) conferences in 2018 and 2019, and published in the New England Journal of Medicine.1
The results showed that patients aged 70 years or younger treated with a regimen based on ibrutinib had a longer life expectancy without disease progression than those patients that were treated with fludarabine, cyclophosphamide, and rituximab (FCR). For those patients treated with ibrutinib, there was a statistically significant progression-free survival (PFS) rate of 87% at 37 months, and a 75% PFS rate for patients on FCR for the same period of time.1
This study was also the first to show the efficacy of a chemotherapy-free regimen of ibrutinib and rituximab over a chemoimmunotherapy regimen of FCR. For the past 20 years, treatment with FCR had been the standard for patients with chronic lymphocytic leukemia.1
“The gold-standard first-line treatment option for many patients with CLL who were fit enough to tolerate an aggressive treatment course had been the intravenous chemoimmunotherapy of FCR. The FDA approval of ibrutinib and rituximab regimen is welcome news for these previously untreated patients who have been looking forward to a nonchemotherapy treatment option. 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 CLL and may enable many to choose a non-chemotherapy treatment option,” said Brian Koffman, MD, CM (retired), Co-Founder and Chief Medical Officer/Executive Vice President, CLL Society, in a press release.1
Koffman B, James D, Tendler C. Janssen/Pharmacyclics news: FDA approves Imbruvica + rituximab for Frontline Chronic Lymphocytic Leukemia [news release]. Chicago, IL: Janssen Pharmaceutical Companies; April 21, 2020. prnewswire.com/news-releases/us-fda-approves-imbruvica-ibrutinib-plus-rituximab-for-the-treatment-of-patients-with-chronic-lymphocytic-leukemia-cll-301044670.html. Accessed April 21, 2020.