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Amgen granted priority review for extended use of Kyprolis

Trial data shows myeloma drug's improvement over Velcade
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Amgen's Kyprolis has been granted priority review by the FDA for patients with relapsed multiple myeloma.

The supplementary new drug application (sNDA) will therefore hope to expand Amgen's current indication to use Kyprolis (carfilzomib) in combination with dexamethasone for patients who have relapsed and have received at least one prior therapy.

If given the green light, the decision would represent the second FDA approval in six months for Kyprolis which was recently approved alongside Celgene's Revlimid (lenalidomide) and dexamethasone.

Sean Harper, executive vice president of R&D at Amgen, said: “Clinicians need a range of options and robust clinical data to make informed choices that can ideally extend the time patients live without their cancer progressing.

“The acceptance of this submission is an important next step toward providing more options for patients with relapsed multiple myeloma.”

The application is based on data from the phase III ENDEAVOR study involving 929 patients, which compared Takeda's Velcade (botezomib) in combination with dexamethasone, with Kyprolis and dexamethasone.

The results showed that patients in the Kyprolis group lived twice as long with median progression-free survival rates standing at 9.4 months versus 18.7 months.

The FDA expects to make a decision on the use of the combination therapy by January 22, 2016 and the outcome could provide an additional alternative treatment option for multiple myeloma, where patients face poor prognosis and outcomes that worsen at each relapse.

Kyprolis has already made good progress in the myeloma marketing achieving a growth in sales from $73m in 2013 to $300m in 2014 and any future progress could help justify the $10.4bn that Amgen paid Kyprolis' developer Onyx Pharmaceuticals in 2013.

The outcome of the priority review will also be important in determining if it can catch up and perhaps eventually overtake Takeda's $2bn-a-year Velcade.

An FDA priority review is assigned to applications for drugs that treat serious conditions and would, if approved, provide significant improvements in safety or effectiveness of treatment.

Article by
Nikhil Patel

21st September 2015

From: Research, Regulatory

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