European CHMP Adopts Positive Opinion For Gilead Sciences, Inc. (GILD)’s Zydelig® (Idelalisib) For The Treatment Of Chronic Lymphocytic Leukemia And Follicular Lymphoma
7/25/2014 9:06:11 AM
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Zydelig® (idelalisib 150 mg film-coated tablets), a first-in-class treatment for patients with chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL), the most common subtype of indolent non-Hodgkin lymphoma (iNHL). The CHMP opinion supports the use of Zydelig in combination with rituximab for the treatment of adult patients with CLL who have received at least one prior therapy or, as first-line treatment in CLL patients in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy and also as monotherapy for the treatment of adult patients with FL that is refractory to two prior lines of treatment. The CHMP’s recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union (EU).
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