FDA approves ibrutinib for MCL

FDA granted accelerated approval to Imbruvica ibrutinib ( PCI-32765) from Pharmacyclics Inc. (NASDAQ:PCYC) and partner Johnson & Johnson (NYSE:JNJ) to treat relapsed or refractory mantle cell lymphoma (MCL) in patients who have received at least one prior therapy. The approval comes well ahead of the Feb. 28 PDUFA date. Imbruvica is already available at a cost of $10,900 for a 30-day supply. According to the drug's label, the median treatment duration was 8.3 months in the open-label Phase II PCYC-1104 trial. Imbruvica's approval was based on data from PCYC-1104, which showed the drug led to an overall response rate (ORR) of 66% in 111 MCL patients. J&J is conducting a confirmatory Phase III trial.

Ibrutinib is still under Priority Review to treat relapsed or refractory chronic lymphocytic leukemia (CLL) or small cell lymphocytic lymphoma (SLL), with a Feb. 28 PDUFA date. J&J's Janssen Biotech Inc. unit and Pharmacyclics are co-developing and co-commercializing ibrutinib -- a Bruton's tyrosine kinase (Btk) inhibitor that covalently binds to cysteine residue 481 -- under a 2011 deal. Pharmacyclics was up $4.15 to $123.82 on Wednesday. ...