Gilead Sciences Gains EU Approval for Cancer Drug Zydelig

Gilead Sciences, Inc. has received approval from the European Commission for Zydelig (idelalisib), 150 mg tablets, an oral treatment for two blood cancers,  chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL). In July, the US Food and Drug Administration approved Zydelig 150 mg tablets for the treatment of three B-cell blood cancers: CLL, FL, and small lymphocytic lymphoma. 

In the EU, 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. 

Source: Gilead Sciences


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