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Amgen's roll-out of myeloma drug Kyprolis reaches UK

Company hopes to gain NICE approval later this year

Amgen

Amgen has launched its new multiple myeloma therapy Kyprolis in the UK - to the delight of patients and doctors who have been anticipating the availability of the drug.

Kyprolis is the first irreversible proteasome inhibitor to reach the UK market and is indicated for use in combination with Celgene's multiple myeloma therapy Revlimid (lenalidomide) and dexamethasone to treat patients who have received at least one prior therapy.

The drug was approved in Europe in November for second-line multiple myeloma therapy based on data from the ASPIRE trial. This showed that patients treated with all three drugs had a progression-free survival of 26 months, compared to just over 17 months for those on Revlimid and dexamethasone alone.

Amgen is launching the drug across the EU on a country-by-country basis as reimbursement is secured. Two weeks ago the company announced it had secured reimbursement approval in Germany and the launch there is underway.

While there have been significant treatment advances for multiple myeloma in recent years, it remains an incurable disease and Kyprolis provides "an important new treatment option" for patients, according to Amgen UK's executive medical director Tony Patrikios.

Along with cholesterol drug Repatha (evolocumab), Kyprolis is expected to be a growth driver for Amgen in the coming years, and its early performance in the market has reinforced that view. Sales of the drug - which was launched in the US in 2012 - rose 55% to reach $512m last year.

Take-up of Kyprolis has accelerated following the addition of new data to the label in the US from the ENDEAVOR trial, showing the drug can double progression-free survival compared to Takeda's £2bn-a-year Velcade (bortezomib) product. The data is currently under review in the EU.

Along with the ASPIRE data, the ENDEAVOR results will form part of the dossier that Amgen intends to submit to the National Institute for Health and Care Excellence (NICE) later this year as it tries to win an agreement to make Kyprolis available on the NHS in England and Wales.

Myeloma UK chief executive Eric Low welcomed the launch and pledged to work closely with Amgen and the UK government "to ensure that patients get access as quickly as possible".

Amgen is hoping to move Kyprolis into the first-line treatment setting in multiple myeloma and is awaiting the results of the CLARION trial, with first data due early next year.

Article by
Phil Taylor

16th February 2016

From: Research

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