Amgen seeks EU approval for expanded Kyprolis indication

Amgen has submitted an application to the European Medicines Agency seeking approval for Kyprolis in an expanded indication.

The company is applying for a variation to the drug's marketing authorisation application to allow it to be used in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

This is based on results from the phase III head-to-head ENDEAVOR study, in which patients with multiple myeloma treated with Kyprolis plus dexamethasone achieved superior progression-free survival compared to those receiving an established alternative therapy.

Dr Sean Harper, executive vice-president of research and development at Amgen, said: "We look forward to continued discussions with health authorities with the goal of bringing new Kyprolis-based regimens to patients in Europe."

The European Commission recently granted marketing authorisation for Kyprolis in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy, following an accelerated assessment.