Amgen’s Kyprolis set to muscle in on myeloma

Amgen could soon have approval for its drug Kyprolis as a second line treatment in multiple myeloma, a therapy area currently being dominated by Celgene.

The FDA has fast-tracked its review of Kyprolis (carfilzomib) for patients who have relapsed after having received at least one prior therapy, and the US regulator has set itself 26 July as the deadline for the decision.

The drug has already been granted a provisional ‘accelerated approval’ in these patients, and the company is now looking to confirm this use.

An approval would be a major boost for Amgen’s drug, which has struggled to gain market share as a third line treatment. Celgene’s rival drug Pomalyst has been far more successful, despite being launched after Amgen’s.

Kyprolis earned $331 million in 2014, compared to the $679 million earned by Pomalyst (known as Imnovid outside the US).

Celgene’s Revlimid combined with dexamethasone is increasingly the standard of care for myeloma, and has now been licensed in the US and Europe for first line use.

Data from Amgen’s ASPIRE study, unveiled last December, showed Kyprolis added major benefits for patients who had relapsed after first line therapy when added to Revlimid. Combined with Revlimid and dexamethasone, Kyprolis extended progression-free survival (PFS) by 8.7 months (from 17.6 months to 26.3 months), compared to Revlimid and dexamethasone alone. The three-drug combination also increased the overall response rate from 67 per cent to 87 per cent.

Amgen has also had success in trials pitting its drug and dexamethasone against Takeda and Janssen’s Velcade, doubling PFS to 18.7 months compared to its rival.

The results have helped the drug recover from a setback last August, when it failed to show superiority to dexamethasone plus optional cyclophosphamide in patients with relapsed and advanced refractory multiple myeloma.

Kyprolis’ new second line data has also just been accepted for ‘accelerated assessment’ by Europe’s regulator the EMA.

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