AbbVie and Janssen are seeking to expand the use of their cancer drug Imbruvica in the US to include the front-line treatment of chronic lymphocytic leukaemia, thereby targeting the largest subset of patients with the disease.
The drug is already on the US market for the treatment of patients with CLL who have received at least one prior therapy and all CLL patients (including treatment-naive) who have the genetic aberration del 17p.
But data from the Phase III RESONATETM-2 (PCYC-1115) trial assessing Imbruvica (ibrutinib) versus chlorambucil showed that the drug also improved progression-free survival and other secondary endpoints such as overall survival and overall response rate in treatment-naive CLL.
“Treatment-naive patients with this disease typically relapse or become refractory to standard chemotherapy, so new options are greatly needed to potentially change the CLL/SLL treatment paradigm," said lead studyJan Burger, Associate Professor, Department of Leukaemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center.
Imbruvica, which is also approved in certain regions for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy and Waldenstrom's macroglobulinemia, is being jointly developed and commercialised by AbbVie company Pharmacyclics and Janssen Biotech.