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Amgen set for Kyprolis label boost after CHMP backing

Multiple myeloma treatment set to add new survival data

Amgen

The Committee for Medicinal Products for Human Use (CHMP) has given the go-ahead for Amgen to add survival data to the labelling for its multiple myeloma treatment Kyprolis (carfilzomib).

Kyprolis, which was initially approved in the EU two years ago after a few missteps, was recently investigated in a phase III trial that pitted the drug against Takeda’s Velcade (boretezomib).

The move was a bit dicey considering Kyprolis’ last head-to-head trial with the proteasome inhibitor in 2016 saw it fail to demonstrate superior progression-free survival.

This time around both Kyprolis and Velcade were studied in combination with dexamethasone, and results demonstrated that Kyprolis reduced the risk of death by 21% and increased overall survival by 7.6 months verses Velcade in patients with relapsed or refractory multiple myeloma.

David Reese, senior vice president of translational sciences and oncology at Amgen, said: “The positive opinion issued by the CHMP underscores our commitment to helping patients live better, longer lives.”

Currently, Kyprolis is approved in the EU for us in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.

The disease itself is as a rare, incurable blood cancer, characterised by the recurring pattern of remission and relapse and accounting for one percent of all cancers.

According to Globocan, a project for cancer research, approximately 39,000 patients are diagnosed with multiple myeloma each year, and around 24,000 patient deaths are reported on an annual basis.

Reese added: “We’re proud to share these results with European regulatory authorities and believe Kyprolis is advancing the standard of care for patients with relapsed or refractory multiple myeloma.”

Article by
Gemma Jones

1st February 2018

From: Regulatory

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