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Amgen aspires to new Kyprolis label in the US and Europe

Appeals to regulators to add survival data to multiple myeloma drug's labelling

Amgen

After a tumultuous beginning Amgen’s Kyprolis has started to pick up the pace, and the multiple myeloma drug could be in-line for stronger labelling after the release of positive phase III data.

The ASPIRE trial looked at patients with relapsing or hard-to-treat multiple myeloma and compared Kyprolis (carfilzomib) with lenalidomide and dexamethasone (Rd) to Rd alone.

Newly-released analysis show Kyprolis exceeded its secondary endpoint of overall survival, reducing the risk of death by 21% over Rd alone. Patients in the trial received 18 cycles of Kyprolis with Rd administered twice-weekly at 27 mg.

Shortly after releasing the results Amgen filed applications with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to add this overall survival data to Kyprolis’ label.

Earlier this year Amgen received more positive results from its ENDEAVOR trial showing the two proteasome inhibitors outperformed Takeda’s Velcade (bortezomib) in relapsed myeloma patients for progression-free survival.

The previous data also proved similar to its newly-released ASPIRE trial.  Patients on the Kyprolis regimen at 56 mg in combination with Rd reduced the risk of death by 21% over Velcade and dexamethasone (Vd) and lived 7.6 months longer than those treated with Vd.

Kyprolis is already approved in the US and EU on the basis of primary analysis of progression-free survival (PFS) in the ASPIRE study.

The drug is also approved in the US as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.

Article by
Gemma Jones

17th July 2017

From: Research

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