Europe backs new leukemia drugs from J&J and Gilead

LONDON Fri Jul 25, 2014 10:29am EDT

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LONDON (Reuters) - Two new leukemia drugs from Johnson & Johnson and Gilead Sciences have been recommended for approval by European regulators, paving the way for formal approval in a couple of months.

The European Medicines Agency said on Friday its experts had issued positive opinions for J&J's ibrutinib, developed with Pharmacyclics, and Gilead's idelalisib.

Ibrutinib, marketed at Imbruvica, was approved by U.S. regulators for treatment of chronic lymphocytic leukemia (CLL) in February, while Gilead's idelalisib, which has the brand name Zydelig, was approved in the United States last month.

The approvals reflect a rapid pace of progress in treating CLL, a slowly progressing form of blood cancer, as scientists develop better ways to target the biological pathways involved in the disease.

Last November, the U.S. Food and Drug Administration also approved Roche's Gazyva and the use of Arzerra, from GlaxoSmithKline and Genmab, was expanded in April 2014 to include CLL.

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