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CHMP backs Zydelig, Imbruvica

July 25, 2014 11:44 PM UTC

EMA's CHMP issued positive opinions for several drugs on Friday, including Zydelig idelalisib from Gilead Sciences Inc. (NASDAQ:GILD) and Imbruvica ibrutinib from Pharmacyclics Inc. (NASDAQ:PCYC) and partner Johnson & Johnson (NYSE:JNJ). The committee backed approval of Zydelig in combination with rituximab to treat chronic lymphocytic leukemia (CLL) in patients who have received at least one prior therapy and as first-line therapy in patients with 17p deletion or tumor protein p53 ( TP53; p53) mutation who are unsuitable for chemo immunotherapy. CHMP also backed the small molecule inhibitor of phosphoinositide 3-kinase (PI3K) delta as monotherapy to treat follicular lymphoma (FL) that is refractory to two prior lines of treatment. FL is a type of indolent non-Hodgkin's lymphoma (NHL).

The CHMP recommendation for Zydelig comes on the heels of FDA approval of the drug to treat CLL and FL as well as small lymphocytic lymphoma (SLL), also a type of indolent NHL (see BioCentury Extra, July 23). ...