FDA approves Imbruvica (ibrutinib) as a first-line treatment for patients with chronic lymphocytic leukaemia (CLL)- AbbVie + Janssen Biotech

AbbVie announced that the FDA has approved Imbruvica (ibrutinib) as a first-line treatment for patients with chronic lymphocytic leukaemia (CLL). The approval is based on data from the randomised, multi-centre, open-label Phase III RESONATE-2 (PCYC-1115) trial, which evaluated the use of ibrutinib versus chlorambucil in 269 treatment-naïve patients with CLL or small lymphocytic lymphoma (SLL) aged 65 years or older. The RESONATE-2 data were previously presented at the American Society of Hematology (ASH) Annual Meeting in December 2015 and also simultaneously published in The New England Journal of Medicine.

Comment: Ibrutinib is jointly developed and commercialised by Pharmacyclics (an AbbVie company) and Janssen Biotech. It is now approved to treat CLL patients regardless of their treatment history (treatment-naïve and previously-treated patients). In addition, ibrutinib is approved to treat high-risk CLL patients with del 17p, a genetic aberration that occurs when part of chromosome 17, the location of the tumour suppressor gene p53, has been lost or deleted.

Competitors include the recently approved anti-CD20 antibody Gazyva (obinutuzumab) from Roche, and the PI3 kinase inhibitor Zydelig (idelalisib) from Gilead Sciences.