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(Adds analyst comment, background, updates share moves)
By Bill Berkrot
Jan 7 (Reuters) - An independent committee recommended alate stage trial of a cancer drug developed by Pharmacyclics Incand Johnson & Johnson be stopped early as it became clear ithelped patients with chronic lymphocytic leukemia (CLL) livelonger, paving the way for additional approval of the medicine.
The announcement of the study's early success byPharmacyclics on Tuesday sent its shares soaring 20percent higher and took J&J shares up by nearly 2percent.
The independent monitoring committee, upon reviewing interimresults of the trial called Resonate, unanimously recommended itbe stopped as ibrutinib was deemed assured of meeting both theprimary goal of significantly delaying progression of thedisease and the secondary goal of extending survival in patientswith relapsed CLL compared with those taking GlaxoSmithKline'sAzerra (ofatumumab).
The committee also recommended that ibrutinib be madeavailable to patients taking the Glaxo drug in the study.
Ibrutinib was approved for sale by the U.S. Food and DrugAdministration in November to treat a rare form of blood cancercalled mantle cell lymphoma under the brand name Imbruvica. Butsome analysts and investors were disappointed the agency did notsimultaneously approve it for CLL, instead setting an approvaldecision date of Feb. 28.
"We believe the IDMC move to stop the study early willresonate quite profoundly with the FDA," Roth Capital Partnersanalyst Joseph Pantginis said in a research note.
Ibrutinib had received the FDA's new breakthrough therapydesignation given to experimental drugs deemed to be potentiallyimportant advances in treating serious diseases.
Wells Fargo Securities analyst Matthew Andrews said in anote that the monitoring committee decision "may provide FDAwith additional regulatory leeway to approve Imbruvica (for CLL)before February 28."
Independent monitoring committees regularly conduct interimanalyses of clinical trials and can either recommend the studycontinue as planned or be stopped early due to safety concernsor because data shows the study drug will clearly succeed inmeeting the goals of the trial.
Pharmacyclics said it has informed the FDA of thecommittee's recommendations, while J&J was providing theinformation to European health regulators.
The safety of the drug in the Phase III trial of 391patients who had failed to be helped by prior therapy wasconsistent with that seen in prior studies, the company said.
Pharmacyclics shares were up $20.86, or 19.8 percent, at$125.92 in midday trading on Nasdaq, while J&J shares were up$1.62, or 1.7 percent at $93.95 on the New York Stock Exchange. (Additional reporting by Vrinda Manocha in Bangalore; Editingby Savio D'Souza and Stephen Powell)
