Amgen says its blood cancer drug gets European backing for extended indication
pharmafile | July 4, 2016 | News story | Research and Development, Sales and Marketing | Amgen, European Commission, Kyprolis, blood cancer, drug trial
Amgen (Nasdaq: AMGN) said the European Commission (EC) has approved a variation to the marketing authorization for its Kyprolis (carfilzomib) to include use in combination with dexamethasone to treat multiple myeloma in patients who have received at least one prior therapy.
The extended indication marks the second approval for Kyprolis by the EC.
Sean Harper, executive vice president of research and development at Amgen, said: “In the Phase III head-to-head trial, Kyprolis in combination with dexamethasone doubled the time patients lived without their cancer progressing, as well as the rates of complete response compared to bortezomib and dexamethasone. Kyprolis-based regimens have now shown superiority over two former standard-of-care treatment options for relapsed multiple myeloma patients, reinforcing Kyprolis’ place as a foundational therapy in this patient population.”
The EC approved the extended indication for Kyprolis based on data from the late-stage trial showing superior progression-free survival (PFS) of 18.7 months compared to 9.4 months for bortezomib plus dexamethasone.
Kyprolis was first approved by the EC in November 2015 for use in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma.
Multiple myeloma is an incurable blood cancer, characterized by a recurring pattern of remission and relapse. It is a rare and very aggressive disease that accounts for approximately one percent of all cancers worldwide. In Europe, about 39,000 patients are diagnosed with multiple myeloma each year and 24,000 patient deaths are reported on an annual basis.
Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed. Kyprolis has been shown to block proteasomes, leading to an excessive build-up of proteins within cells. In some cells, Kyprolis can cause cell death, especially in myeloma cells because they are more likely to contain a higher amount of abnormal proteins.
Anjali Shukla
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