The company has submitted a new drug application for ibrutinib to the FDA that included data from two pivotal Phase 2 studies, one in relapsed/refractory CLL/SLL and one in relapsed/refractory MCL.
The novel Bruton’s tyrosine kinase inhibitor is being jointly developed by Janssen and Pharmacyclics as therapy for B-cell malignancies and will be co-commercialized in the US.
Janssen global oncology head Peter Lebowitz said, "Both companies recognize that there is great unmet need among these patient populations, and together in close collaboration with the FDA, as part of its Breakthrough Therapy Designation pathway, we have been able to accelerate the ibrutinib development program for the benefit of patients."
If approved, ibrutinib will become the first oral BTK inhibitor to address an unmet medical need in two B-cell malignancies.