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UPDATE 1-J&J, Pharmacyclics leukemia drug succeeds in late-stage study
January 7, 2014 / 3:45 PM / 4 years ago

UPDATE 1-J&J, Pharmacyclics leukemia drug succeeds in late-stage study

(Adds details, background, J&J share movement)

Jan 7 (Reuters) - Pharmacyclics Inc said its cancer drug, Imbruvica, met its main goal of increasing patients’ survival without their cancer worsening in a late-stage trial testing it for a rare blood disorder called chronic lymphocytic leukemia.

Pharmacyclics’s stock rose 17 percent after the company also said an independent safety committee recommended halting the trial early. Shares of Johnson & Johnson, its partner, rose about 2 percent.

The drug was approved by the U.S. Food and Drug Administration in November to treat a rare form of blood cancer called mantle cell lymphoma, disappointing some analysts who expected it to be simultaneously approved for chronic lymphocytic leukemia.

Pharmacyclics said on Tuesday that the drug showed statistically significant improvement in the overall survival of patients with chronic lymphocytic leukemia.

The company said it informed the FDA of the committee’s recommendations, while Johnson & Johnson’s unit, Janssen, had informed the European health regulators.

The late-stage study tested the drug in comparison with another cancer drug, ofatumumab, on patients who had failed at least one prior treatment.

Pharmacyclics said the safety of the drug, known generically as ibrutinib, was consistent with prior studies.

Pharmacyclics shares rose 17 percent to $122.87 in early trading on Tuesday on the Nasdaq. Shares of Johnson & Johnson rose about 2 percent to $93.19 on the New York Stock Exchange. (Reporting By Vrinda Manocha in Bangalore; Editing by Savio D‘Souza)

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