FDA approve ibrutinib and rituximab combination for CLL

Following positive results gleaned from the E1912 trial (NCT02048813), the U.S. Food and Drug Administration (FDA) has expanded the indication for ibrutinib to include its combination with rituximab for the initial treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

E1912 was a randomized (2:1), multicenter, open-label, actively-controlled trial of ibrutinib with rituximab compared to fludarabine, cyclophosphamide, and rituximab (FCR). Consisting of 529 patients ≤70 years old with treatment-naïve CLL or SLL, patients were administered with ibrutinib at 420 mg daily until disease progression or unacceptable toxicity. Patients with 17p deletion were excluded.

With progression-free survival (PFS) being the key measurement of efficacy, the trial demonstrated a statistically significant improvement in PFS for patients receiving ibrutinib plus rituximab compared to FCR (HR 0.34; 95% CI: 0.22, 0.52; p<0.0001).

Speaking at ASH 2019, Jacqueline Barrientos, MD, Northwell Health, New York, NY, discusses the extended follow-up results from the E1912 trial in more detail.

Thrombocytopenia, diarrhea, fatigue, musculoskeletal pain, neutropenia, rash, anemia, bruising, and nausea were the most common adverse reactions (≥30%) reported in patients receiving ibrutinib.

The recommended dose of ibrutinib is 420 mg OD, taken orally water. Initiated in Cycle 2, Rituximab was administered at 50 mg/m2 on Day 1, 325 mg/m2 on Day 2, and 500 mg/m2 on Day 1 of 5 subsequent cycles, for 6 total cycles.

Written by Thomas Southgate

References

The U.S. Food and Drug Administration (FDA). FDA approves ibrutinib plus rituximab for chronic lymphocytic leukemia. Available from: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-ibrutinib-plus-rituximab-chronic-lymphocytic-leukemia (Last accessed 23/04/2020).