WASHINGTON (dpa-AFX) - Cell Therapeutics Inc (CTIC) Friday announced that the Committee for Medicinal Products for Human Use, or the CHMP, of the European Medicines Agency may issue an opinion on the company's Marketing Authorization Application, or MAA, for Pixuvri in mid-February. The company stated that the expectation follows its discussion with the EMA. The company further added that it will l continue to work with the CHMP on the Summary of Product Characteristics and other labeling items for Pixuvri. The company is seeking an authorization to market Pixuvri in the E.U. for the treatment of adult patients with multiple relapsed or refractory aggressive non-Hodgkin's B cell lymphomas . If approved by the EMA, Pixuvri would address an unmet medical need, as there are no approved therapies for these patients.
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