The approval was based on data from pivotal Phase 3 ASPIRE trial which showed that patients treated with Kyprolis in combination lived nearly nine months longer without disease progression compared to common treatment course.
The primary endpoint of the study was progression-free survival, defined as the time from randomization to disease progression or death due to any cause, whichever is earlier.
Overall survival, overall response rate, duration of response, disease control rate, health-related quality of life and safety were secondary endpoints.
Amgen executive vice president of research and development Sean Harper said: "The approval of Kyprolis in combination provides physicians and patients across Europe with an important new treatment option for relapsed multiple myeloma, helping to address a real unmet need for this rare blood cancer."
Multiple-myeloma is a cancer of plasma cells and grows in bone marrow. About 39,000 Europeans are diagnosed with multiple-myeloma and 24,000 patients die from the disease each year.
Kyprolis is currently approved in the US in combination with lenalidomide and dexamethasone to treta patients with multiple myeloma who have received one to three prior lines of therapy.
Amgen’s subsidiary Onyx Pharmaceuticals holds development and commercialization rights to Kyprolis globally, excluding Japan.