Imbrutinib (Imbruvica, AbbVie, Janssen) plus obinutuzumab (Gazyva, Roche) has received FDA approval for adults with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
The news marks the tenth approval for inbrutinib in six different disease areas since 2013.
The combination treatment is the first chemotherapy-free, anti-CD20 treatment for CLL and SLL for the U.S. market. Imbrutinib is a first-in-class, oral, once-daily therapy that primarily works by inhibiting the Bruton's tyrosine kinase (BTK) enzyme.
Datafrom the phase 3 iLLUMINATE study showed that the combination treatment of imbrutinib and obinutuzumab significantly improved progression-free survival (PFS) compared to chlorambucil plus obinutuzumab. Patients treated with the imbrutinib–obinutuzumab combination had a 77% reduction in the risk of progression or death compared to the chemotherapy cohort. The combination regimen also showed an 85% reduction in risk of progression or death compared to chlorambucil plus obinutuzumab when evaluating PFS in patients with high-risk disease.
CLL is one of the two most common forms of leukemia in adults, with around 115,000 patients in the U.S. and about 20,000 new diagnoses annually. SLL is a slow-growing lymphoma similar to CLL. Both leukemias occur primarily in people aged 65 to 70 years old.
The most common adverse reactions reported in iLLUMINATE study participants treated with imbrutinib plus obinutuzumab were neutropenia, thrombocytopenia, rash, diarrhea, musculoskeletal pain, bruising, cough, infusion-related reaction, hemorrhage, and arthralgia.