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Amgen's Kyprolis wins new indication in Europe

Regulators have handed the treatment a less restrictive licence in multiple myeloma 

Amgen's cancer treatment Kyprolis has won a new indication from European authorities that should allow it to be used more widely.

The drug's second indication in less than a year will let it be used with dexamethasone alone in adults with multiple myeloma who have received at least one prior therapy.

Last November it was approved in Europe in combination with Celgene's Revlimid (lenalidomide) as well as dexamethasone in this therapy area, after receiving the green light in the US more than three years ago.

The European Commission has been convinced to allow the new variation based on the head-to-head Phase III ENDEAVOR study.

This showed that Kyprolis (carfilzomib) plus dexamethasone offered progression-free survival (PFS) for patients with multiple myeloma of 18.7 months - compared to 9.4 months in those receiving Janssen's Velcade (bortezomib) plus dexamethasone.

Sean Harper, executive vice president of R&D at Amgen, said: “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.”

In addition to its success with PFS, the combination achieved a higher overall response rate than Velcade and dexamethasone (76.9% versus 62.6%). There is not yet sufficient data to make an assessment on overall survival.

One secondary endpoint, the rate of complete response or better, was double in patients treated with the new combination rather than Velcade and dexamethasone (12.5% versus 6.2%).

Amgen says tolerability was similar in the two arms of the trial. The US Food and Drug Administration approved the supplemental New Drug Application based on ENDEAVOR in January.

Multiple myeloma is a rare, incurable blood cancer which is characterised by resistance to treatment: in Europe, around 39,000 patients are diagnosed each year and there are 24,000 patient deaths annually.

Kyprolis received accelerated assessment from the EMA and orphan drug designation in 2008. The latest extension to its indication will be a relief to Amgen: last year Kyprolis failed to meet objectives in a phase III trial comparing the drug to steroid therapy and cyclophosphamide for relapsed and advanced refractory myeloma.

Article by
Adam Hill

5th July 2016

From: Regulatory



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