US regulators have expanded the use of Johnson & Johnson group Janssen and AbbVie’s cancer drug Imbruvica to include its first-line use in chronic lymphocytic leukaemia (CLL), offering patients the first chemotherapy-free option at this stage of their treatment pathway.
The decision means that the drug - a first-in-class, oral, once-daily therapy that inhibits the Bruton's tyrosine kinase (BTK) protein, which plays an important role in the survival and spread of malignant B cells - is now cleared to treat CLL patients regardless of their treatment history. Imbruvica (ibrutinib) is also cleared to treat all patients who have the genetic aberration del 17p.
Commenting on the approval, Michael Severino, AbbVie’s chief scientific officer, said it "represents a significant leap forward for patients diagnosed with CLL who may want to consider an alternative first-line treatment to traditional chemotherapy".
The green light was based on data from the randomised, multi-center, open-label Phase III RESONATE-2 (PCYC-1115) trial, which showed that Imbruvica improved progression-free survival and other secondary endpoints such as overall survival and overall response rate in treatment-naive CLL patients compared to those receiving treatment with chlorambucil.
"The progression-free survival data seen in these previously untreated CLL patients are strong and encouraging," stressed lead study investigator Jan Burger, Associate Professor, Department of Leukaemia, The University of Texas MD Anderson Cancer Center, Houston, Texas. “This is especially important for first-line CLL patients, when considering the safety profile," he noted.