From here:
Germany's Institute for Quality and Efficiency in Health Care (IQWiG) said in a preliminary benefit assessment that cancer drug Pixuvri pixantrone from Cell Therapeutics Inc. (NASDAQ:CTIC; Milan:CTIC) provides "no additional benefit" over patient-individualized care because the company did not submit "suitable" data. Germany's Federal Joint Committee (G-BA) requested that Cell Therapeutics compare Pixuvri -- which is approved to treat multiply relapsed or refractory aggressive non-Hodgkin's B cell lymphoma -- to patient-individualized care, which the agency said could include at least 11 different therapeutic options.
IQWiG said Cell Therapeutics compared Pixuvri to patients treated with etoposide or ifosfamide monotherapy, which are not approved as monotherapy in Germany to treat aggressive non-Hodgkin's B cell lymphoma. The institute said that studies where patients are not treated according to approved regimens "could be relevant" for a preliminary benefit assessment as long as a company proves the treatments are comparable to therapies approved for the indication. IQWiG said Cell Therapeutics did not provide information showing this. The company has until March 22 to respond. A final benefit assessment from G-BA is expected mid-May.
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