Kite, a Gilead company announced that the European Medicines Agency’s, or EMA, Committee for Medicinal Products for Human Use, or CHMP, has issued a positive opinion on the company’s marketing authorization application, or MAA, for Yescarta as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma, or DLBCL, and primary mediastinal large B-cell lymphoma, or PMBCL, after two or more lines of systemic therapy. Axicabtagene ciloleucel is a chimeric antigen receptor T cell therapy that modifies a patient’s own T cells to recognize and attack cancer cells and has the potential to induce complete responses in a proportion of patients with aggressive forms of non-Hodgkin lymphoma, or NHL. Axicabtagene ciloleucel was granted prime status by the EMA in May 2016. The CHMP positive opinion was adopted following review by European Union regulators, including the Committee for Advanced Therapies and the CHMP. The recommendation will now be reviewed by the European Commission , which has the authority to approve medicines for use in the 28 countries of the EU, Norway, Iceland and Liechtenstein.
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