FDA approves Imbruvica for Waldenstrom's

FDA approved an sNDA for Imbruvica ibrutinib from Pharmacyclics Inc. (NASDAQ:PCYC) and the Janssen Biotech Inc. unit of Johnson & Johnson (NYSE:JNJ) to treat Waldenstrom's macroglobulinemia, well ahead of its April 17 PDUFA date. The drug had breakthrough designation from FDA. Pharmacyclics said Imbruvica is the only FDA-approved treatment for Waldenstrom's, a form of B cell lymphoma.

The agency granted Imbruvica full approval last July as a first-line therapy to treat chronic lymphocytic leukemia (CLL) in patients with 17p deletion and to treat CLL in patients who have received one prior therapy. It received accelerated approval in November 2013 to treat mantle cell lymphoma (MCL) (see BioCentury Extra, July 28, 2014). ...