FDA Approves Ibrutinib Plus Rituximab for Chronic Lymphocytic Leukemia

The FDA has approved ibrutinib (Imbruvica, Janssen Pharmaceutical Companies of Johnson & Johnson) in combination with rituximab for treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in patients aged 70 years or younger who are new to therapy, according to a press release.

Ibrutinib is a once-day orally administered Bruton’s tyrosine kinase (BTK) inhibitor that blocks the PTK protein and may help move abnormal B cells out of lymph nodes, bone marrow, and other organs.

The FDA’s approval stems from clinical data from the phase 3 E1912 study, which evaluated 529 previously untreated patients with CLL who were aged 70 years or younger, with a median age of 58 years. Participants were randomly assigned to receive ibrutinib plus rituximab or the chemoimmunotherapy regimen fludarabine, cyclophosphamide, and rituximab (FCR). The E1912 study results showed that the participants treated with ibrutinib plus rituximab lived longer without disease progression, with a progression-free survival (PFS) rate of 88% at 37 months compared with participants treated with FCR, with a PFS rate of 75%.

The recommended dosage for the treatment of CLL/SLL is 420 mg, taken orally once daily, until the disease progresses, or unacceptable toxicity occurs. Ibrutinib can be administered alone, in combination with rituximab or obinutuzumab, or in combination of bendamustine and rituximab (BR).

The most common adverse reactions identified were fatigue, musculoskeletal pain, diarrhea, rash, hypertension, arthralgia, nausea, and headache, among others.

"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, non-chemoimmunotherapy option," said Brian Koffman, MD, CM (retired), co-founder and chief medical officer/executive vice president, CLL Society. “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."

Disclosures:

1. U.S. FDA Approves IMBRUVICA® (ibrutinib) Plus Rituximab for the Treatment of Patients with Chronic Lymphocytic Leukemia (CLL). News Release. Janssen; April 21, 2020. Accessed April 21, 2020. https://www.janssen.com/us-fda-approves-imbruvica-ibrutinib-plus-rituximab-treatment-patients-chronic-lymphocytic-leukemia