AbbVie company Pharmacyclics and Janssen Biotech are jointly developing and commercializing Imbruvica, which is oral, once-daily therapy that inhibits Bruton’s tyrosine kinase (BTK) protein.
The breakthrough therapy designation is supported by data from a Phase 1b/2 clinical study assessing the safety and efficacy of ibrutinib in patients with steroid-dependent or refractory cGVHD.
AbbVie said ibrutinib demonstrated crucial preclinical data, a novel mechanism of action and better early clinical efficacy data supporting an enhancement in cGVHD depending on the National Institutes of Health (NIH) consensus cGVHD Activity Assessment.
The FDA earlier granted breakthrough therapy designations to Imbruvica to treat relapsed or refractory mantle cell lymphoma (MCL), Waldenström’s macroglobulinemia (WM), and chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in patients with a deletion of the short arm of chromosome 17 (del 17p).
Pharmacyclics oncology head Danelle James said: "This fourth Breakthrough Therapy Designation from the FDA shows the promise of Imbruvica and its unique mechanism of action as a potential therapy beyond blood cancers, including chronic graft-versus-host-disease, a severe inflammatory condition with currently no approved therapies specifically for these patients."
Imbruvica blocks signals that tell malignant B cells to multiply and spread in an uncontrolled manner.
It is being studied alone and in combination with other treatments in various blood and solid tumor cancers and other severe illnesses.
Image: AbbVie US Headquarters – Angle 3. Photo: courtesy of AbbVie Inc. North Chicago, Illinois, U.S.A.