Ibrutinib receives third breakthrough designation
Pharmacyclics Inc. (NASDAQ:PCYC) said FDA granted breakthrough drug designation to ibrutinib to treat chronic lymphocytic leukemia (CLL) or small cell lymphocytic lymphoma (SLL) in patients with chromosome 17p deletion. In February, FDA granted ibrutinib breakthrough designation for relapsed or refractory mantle cell lymphoma (MCL) and Waldenstrom's macroglobulinemia. Ibrutinib is in the Phase II RESONATE-17 trial to treat CLL and SLL patients with chromosome 17p deletion and the Phase III RESONATE trial in CLL and SLL patients without the mutation. The compound is also in Phase III testing to treat MCL. Ibrutinib is a Bruton's tyrosine kinase (Btk) inhibitor that covalently binds to cysteine residue 481. Pharmacyclics was up $1.21 to $76.76 on Monday. ...