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Amgen’s Kyprolis Meets Phase 3 Primary Goal

Amgen’s Kyprolis Meets Phase 3 Primary Goal
By: Bill Ashton
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Amgen Inc. (AMGN) said today that its pipeline drug, Kyprolis, which is being developed for the treatment of blood cancer, met its primary end point. In the Phase 3 ASPIRE trial, the drug was being tested to see if it allows patients to live longer without the afflicting disease worsening.

In the study, 792 patients who had relapsed into multiple myeloma were tested. The results showed that when patients were injected with Kyprolis, along with Revlimid and a small dose of dexamethasone, they had a median progression-free survival (PFS) of 26.3 months versus the median PFS of 17.6 months of those only administered Revlimid and dexamethasone.

On the safety criteria, the results were line with the Kyprolis safety profile in the US, as were the cardiac complications. The company will be presenting the full results of the trial at the annual meeting of the American Society of Hematology later this year.

The successful approval of Kyprolis will be huge news for patients suffering from multiple myeloma. Currently there are about 70,000 people in the US suffering from the second-most common form of blood cancer. Globally, some 230,000 people are affected by the disease.

Kyprolis had been approved by the Food and Drug Administration in 2012 for treating patients who had previously been treated with two other therapies. The drug became part of Amgen’s portfolio through its acquisition of Onyx Pharmaceutical last year for $10.4 billion.

Amgen closed up almost 2.5% on the news today. Year-to-date, the company has returned about 9.86%.

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