Janssen submits ibrutinib MAA

The Janssen-Cilag International N.V. unit of Johnson & Johnson (NYSE:JNJ) submitted an MAA to EMA for ibrutinib ( PCI-32765) to treat relapsed or refractory mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) or small cell lymphocytic lymphoma (SLL). The product is under Priority Review for the indications in the U.S., with a Feb. 28, 2014, PDUFA date. The Bruton's tyrosine kinase (Btk) inhibitor that covalently binds to cysteine residue 481 has breakthrough therapy designation from FDA for MCL and for CLL or SLL in patients with chromosome 17p deletion, as well as for Waldenstrom's macroglobulinemia. ...