Ibrutinib regulatory update

Pharmacyclics said that FDA granted breakthrough drug designation to ibrutinib as monotherapy to treat relapsed or refractory mantle cell lymphoma (MCL) and Waldenstrom's macroglobulinemia. The compound is in Phase III testing for MCL. Pharmacyclics said it expects to finalize a regulatory submission for MCL by year end. Ibrutinib is a Bruton's tyrosine kinase (Btk) inhibitor that covalently binds to cysteine residue 481. In 2011, Pharmacyclics partnered with Johnson & Johnson's Janssen Biotech Inc. subsidiary to co-develop and co-commercialize Pharmacyclics' ibrutinib (see BioCentury, Dec. 12, 2011). ...