German institute says Cell Therapeutics did not provide sufficient data for drug cancer drug assessment
IQWiG said the cancer drug Pixurvi pixantrone provided no additional benefit over patient-individualized care because the company did not turn in appropriate data on the drug's effects.
Germany's Federal Joint Committee requested that Cell Therapeutics use the opportunity to compare Pixurvi, which has been approved to treat multiply relapsed or refractory aggressive non-Hodgkin's B cell lymphoma, to 11 different therapeutic options that comprise patient-individualized care.
IQWiG said the company did compare the results of the medication on patients to those treated etoposide or ifosfamide monotherapy. Neither are approved as monotherapy against non-Hodgkin's B cell lymphoma in Germany.
The institute reported that studies where patients are not treated according to previously approved regimens could be relevant in preliminary benefit assessments as long as the company can prove the treatments are comparable to therapies that are already approved for the indication. IQWiG said Cell Therapeutics did not provide the relevant data.
The institute said Cell Therapeutics has until March 22 to respond to the finding. The Federal Joint Committee said a final benefit assessment can be expected to be released in mid-May.