European Commission approves Amgen’s cancer drug Kyprolis in combo therapy
pharmafile | November 20, 2015 | News story | Research and Development, Sales and Marketing |
The European Commission (EC) has today granted marketing authorization for Amgen’s Kyprolis (carfilzomib) in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
Kyprolis is the first irreversible proteasome inhibitor approved in the European Union (EU) for use in combination treatment of patients with relapsed multiple myeloma.
Multiple myeloma is an incurable blood cancer, characterised by a recurring pattern of remission and relapse. The rare and very aggressive orphan disease accounts for approximately one percent of all cancers. In Europe, approximately 39,000 patients are diagnosed with multiple myeloma each year and 24,000 patient deaths are reported on an annual basis.
“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,” says Sean Harper, executive vice president of Research and Development at Amgen. “Multiple myeloma is a complex blood cancer that often becomes resistant to treatment, which is why there is a need for new therapeutic options that provide deep and durable responses to extend the time patients live without their disease progressing.”
The EC approved Kyprolis based on data from the pivotal Phase 3 ASPIRE trial, which showed that patients treated with Kyprolis in combination with lenalidomide and dexamethasone (a regimen known as KRd) had increased median time to progressive disease (PD) or death by 8.7 months compared to patients treated with lenalidomide and dexamethasone.
Professor Meletios Dimopoulos, Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine, comments: “In clinical studies, approximately one out of three patients achieved a complete response or better on the Kyprolis in combination with lenalidomide and dexamethasone arm, which is three times more frequent than in the lenalidomide and dexamethasone arm.
“In addition, the regimen provided patients with more than two years without disease progression. These results are significant for patients with relapsed multiple myeloma, who are faced with worse outcomes each time they experience a relapse.”
Kyprolis received an accelerated assessment from the European Medicines Agency (EMA), and orphan drug designation in 2008, given to medicines intended for the treatment, prevention or diagnosis of a disease that is life threatening and has a prevalence in the EU of no more than five in 10,000 people.
Amgen said it also plans to submit data from the Phase 3 ENDEAVOR trial for potential authorisation of Kyprolis in combination with dexamethasone in the EU. This data also serves as the basis of the supplemental New Drug Application of Kyprolis in combination with dexamethasone for patients with relapsed multiple myeloma, which has been accepted for priority review by the US Food and Drug Administration (FDA).
Joel Levy
