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Amgen’s Kyprolis approved in Europe

Multiple myeloma drugwins licence three years after gaining US approval

Amgen's Kyprolis has been approved in Europe in combination with Celgene's Revlimid and dexamethasone for the treatment of adults with multiple myeloma.

The approval follows the recommendation of European Medicines Agency (EMA) advisors and comes more than three years after Kyprolis (carfilzomib) was approved in the US.

The phase II data which formed the base for US approval was insufficient for an EU approval and additional data from a larger phase III trial needed to be collected before the EMA would give it the green light. 

The European approval is based on the pivotal ASPIRE trial, which examined Kyprolis, lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone.

The study found patients treated with Kyprolis had median progression-free survival (PFS) of 26.3 months compared to 17.6 months for patients treated with lenalidomide and dexamethasone alone.

Sean Harper, executive vice president of research and development at Amgen, 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 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.”

Kyprolis received accelerated assessment from the EMA and orphan drug designation in 2008.

The approval will come as good news for Amgen as earlier in August Kyprolis failed to meet objectives in a phase III trial comparing the drug to steroid therapy and cyclophosphamide for relapsed and advanced refractory myeloma.

Nevertheless, analysts have estimated the sales potential of Kyprolis as high as $2bn a year at peak. 

Article by
Nikhil Patel

20th November 2015

From: Regulatory



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