Ibrutinib gets FDA breakthrough designation

Pharmacyclics Inc. (NASDAQ:PCYC) said late Tuesday 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, which is partnered with Johnson & Johnson (NYSE:JNJ), is in Phase III testing for MCL; Pharmacyclics said it expects to finalize a regulatory submission for the indication by year end. Ibrutinib is a Bruton's tyrosine kinase (Btk) inhibitor that covalently binds to cysteine residue 481. Pharmacyclics was off $0.33 to $70.37 on Tuesday.

Separately, FDA told BioCentury that it has granted breakthrough designation to five drug candidates. According to the agency it has denied five requests and 12 are pending. FDA does not disclose sponsors or drug candidates. ...