The U.S. Food and Drug Administration (FDA) has cleared the use of Imbruvica, a cancer drug jointly owned by AbbVie Inc. and Johnson and Johnson, for treatment of chronic lymphocytic leukemia (CLL).
According to AbbVie Inc., Imbruvica is now approved to treat CLL patients regardless of their treatment history (treatment-naïve and previously-treated patients). Additionally, the expanded approval establishes Imbruvica as the first FDA-approved, chemotherapy-free treatment option for CLL patients.
The approval is based on data from the randomized, multi-center, open-label Phase 3 Resonate-2 trial, which evaluated the use of Imbruvica versus chlorambucil in 269 treatment-naïve patients with CLL or small lymphocytic lymphoma (SLL) aged 65 years or older. Trial results showed that Imbruvica helped significantly lower death risk by 85%.
Earlier this month, Britain's healthcare cost-effectiveness agency, the National Institute for Health and Care Excellence (NICE), rejected Imbruvica citing it wasn't confident the drug, with a list price of $78,000 per year, represented an effective use of resources.