European Commission grants marketing authorization for Gilead’s Zydelig (idelalisib) for the treatment of chronic lymphocytic leukemia and follicular lymphoma

EMA

Gilead Sciences, Inc. today announced that the European Commission has granted marketing authorization for Zydelig (idelalisib), 150 mg tablets, a first-in-class oral treatment for two incurable blood cancers - chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL). For the treatment of CLL, Zydelig has been approved for use in combination with rituximab for patients who have received at least one prior therapy; or as first-line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy. For the treatment of FL, Zydelig has been approved as a monotherapy in patients who are refractory to two prior lines of treatment. Zydelig inhibits PI3K delta, a protein that is overexpressed in many B-cell malignancies and plays a role in the viability, proliferation and migration of these cancer cells.

CLL and FL are slow-growing incurable blood cancers that can lead to life-threatening complications such as anemia, serious infection and bone marrow failure requiring treatment. The goal of therapy for patients with these cancers is to improve overall survival and quality of life.

For more details, go to: http://www.gilead.com/news/press-releases/2014/9/european-commission-grants-marketing-authorization-for-gileads-zydelig-idelalisib-for-the-treatment-of-chronic-lymphocytic-leukemia-and-follicular-lymphoma

Michael Wonder

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Michael Wonder

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