Genmab — November 2016
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Hvem er det der kriges
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Ninlaro blev i foråret i første omgang afvis af CHMP i EU. Men er nu taget til nåde. Begrundelsen den gang var: “The CHMP considered that the data from the [TOURMALINE-MM1] study were insufficient to demonstrate a benefit of Ninlaro in the treatment of multiple myeloma. The company had proposed restricting the use of the medicine to patients whose disease is more difficult to treat and had come back after one previous treatment, and to those whose disease had come back after at least two
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previous treatments. However, the data in these subgroups were not compelling enough and the rationale for assuming greater effectiveness in these patients was not clear.
“Therefore, the CHMP was of the opinion that, based on the currently available data, the benefits of Ninlaro did not outweigh its risks and recommended that it be refused marketing authorization.”
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