J&J, Pharmacyclics drug gets U.S. approval for leukemia

by Reuters
Wednesday, 12 February 2014 18:19 GMT

Feb 12 (Reuters) - U.S. health regulators on Wednesday approved the Johnson & Johnson and Pharmacyclics Inc cancer drug Imbruvica to treat chronic lymphocytic leukemia, a slowly progressing form of blood cancer.

The Food and Drug Administration decision marks the second approval recently for the medicine, known chemically as ibrutinib. In November, the drug won U.S. approval to treat a rare and aggressive form of non-Hodgkin lymphoma called mantle cell lymphoma in patients who have received prior treatment with at least one other therapy.

The latest approval is also for so-called second line therapy after at least one prior treatment fails or stops working, the FDA said.

"Today's approval provides an important new treatment option for CLL patients whose cancer has progressed despite having undergone previous therapy," Richard Pazdur, head of the FDA's Office of Hematology and Oncology Products, said in a statement.

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