The European Medicines Agency has accepted Amgen/Onyx’ Marketing Authorisation Application for Kyprolis (carfilzomib) as a treatment for multiple myeloma.
The companies are hoping to get approval for the injection as a treatment for patients with relapsed MM who have received at least one prior therapy.
The Agency said it will undertake an accelerated assessment of the drug, which already holds Orphan Drug status in the region.
MM is an incurable blood cancer affecting around 89,000 people in Europe.
AMG 416 hits PhIII targets
Meanwhile, Amgen has released Phase III data showing that its novel calcimimetic agent AMG 416 is ‘non-inferior’ to cinacalcet in reducing parathyroid levels in kidney disease patients receiving dialysis who have developed secondary hyperparathyroidism (SHPT).
It was also found that AMG 416 was significantly superior to cinacalcet in the proportion of patients achieving greater than 50% (52.4% versus 40.2%) and greater than 30% (68.2% versus 57.7%) reduction of PTH from baseline.