FDA clears AbbVie, Johnson & Johnson's Imbruvica for first-line treatment of CLL

The FDA approved AbbVie and Johnson & Johnson's Imbruvica (ibrutinib) as a first-line treatment for patients with chronic lymphocytic leukaemia (CLL), the companies announced Friday. AbbVie chief scientific officer Michael Severino said "this approval represents a significant leap forward for patients diagnosed with CLL who may want to consider an alternative first-line treatment to traditional chemotherapy."

The expanded approval of the therapy was supported by findings from the Phase 3 RESONATE-2 study, which compared the Bruton's tyrosine kinase inhibitor with chlorambucil in 269 treatment-naïve patients aged 65 years or older with CLL or small lymphocytic lymphoma. Study results, which were unveiled in December 2015, showed that Imbruvica reduced the risk of death or disease progression by 84 percent versus chlorambucil. Additionally, the median progression-free survival was 18.9 months in the chlorambucil arm, while it was not reached in the Imbruvica group.

The therapy was initially granted approval by the FDA under an accelerated review process in November 2013 for the treatment of mantle cell lymphoma (MCL) in patients who received at least one prior therapy. Imbruvica was later authorised in the US for the treatment of CLL in patients who received at least one prior therapy and for CLL in patients featuring the 17p deletion. The drug was most recently approved for use in the treatment of Waldenstrom's macroglobulinaemia.

AbbVie obtained rights to the drug as part of its $21-billion acquisition of Pharmacyclics last year.

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