J&J, Pharmacyclics leukemia drug improves survival in study

Tue Jan 7, 2014 12:52pm EST

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(Reuters) - An independent committee recommended a late stage trial of a cancer drug developed by Pharmacyclics Inc and Johnson & Johnson be stopped early as it became clear it helped patients with chronic lymphocytic leukemia (CLL) live longer, paving the way for additional approval of the medicine.

The announcement of the study's early success by Pharmacyclics on Tuesday sent its shares soaring 20 percent higher and took J&J shares up by nearly 2 percent.

The independent monitoring committee, upon reviewing interim results of the trial called Resonate, unanimously recommended it be stopped as ibrutinib was deemed assured of meeting both the primary goal of significantly delaying progression of the disease and the secondary goal of extending survival in patients with relapsed CLL compared with those taking GlaxoSmithKline's Azerra (ofatumumab).

The committee also recommended that ibrutinib be made available to patients taking the Glaxo drug in the study.

Ibrutinib was approved for sale by the U.S. Food and Drug Administration in November to treat a rare form of blood cancer called mantle cell lymphoma under the brand name Imbruvica. But some analysts and investors were disappointed the agency did not simultaneously approve it for CLL, instead setting an approval decision date of February 28.

"We believe the IDMC move to stop the study early will resonate quite profoundly with the FDA," Roth Capital Partners analyst Joseph Pantginis said in a research note.

Ibrutinib had received the FDA's new breakthrough therapy designation given to experimental drugs deemed to be potentially important advances in treating serious diseases.

Wells Fargo Securities analyst Matthew Andrews said in a note that the monitoring committee decision "may provide FDA with additional regulatory leeway to approve Imbruvica (for CLL) before February 28."

Independent monitoring committees regularly conduct interim analyses of clinical trials and can either recommend the study continue as planned or be stopped early due to safety concerns or because data shows the study drug will clearly succeed in meeting the goals of the trial.

Pharmacyclics said it has informed the FDA of the committee's recommendations, while J&J was providing the information to European health regulators.

The safety of the drug in the Phase III trial of 391 patients who had failed to be helped by prior therapy was consistent 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; Editing by Savio D'Souza and Stephen Powell)

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