The US FDA has granted a priority review to Amgen’s Kyprolis as a second-line therapy for multiple myeloma, setting it up for possible approval in late July.
Kyprolis (carfilzomib) is already approved in the US as a third-line option in multiple myeloma patients. However, a green light – in patients with relapsed multiple myeloma who have received just one prior therapy or more – will allow it to tap into a much larger patient population.
Second-line use will boost sales – particularly as patients will be on the drug for longer – and also allow Kyprolis to compete directly with rivals in the increasingly competitive myeloma market.
The filing is underpinned by data from the phase III ASPIRE trial, which showed that patients given Kyprolis, Celgene’s Revlimid (lenalidomide) and dexamethasone had greater progression-free survival than those taking the latter two drugs alone, with the median duration of response of 28.6 months compared to 21.2 months.
Another trial intended to support the ASPIRE data called FOCUS – which compared the drug to steroid therapy and cyclophosphamide in relapsed myeloma – failed to show efficacy, although Amgen has indicated it is confident it can secure approval based on the ASPIRE data alone.
Revlimid is the leading first-line therapy for myeloma by some margin, with sales approaching $5bn last year. For now, competition is fiercest in the second-line market with combatants such as Takeda’s $2bn-a-year Velcade (bortezomib) and Celgene’s Pomalyst (pomalidomide), which made $680m last year.
Kyprolis has made a somewhat less impressive start with sales of $331m in 2014, which in common with Pomalyst was its first full-year on the market, although analysts have predicted it could swell to $2bn a year or more provided it can gain approval for earlier use. That level of sales performance will be needed to justify the $10.4bn Amgen paid for Kyprolis’ developer Onyx Pharmaceuticals in 2013.
Amgen is also taking a more direct approach to competing with its rivals, recently reported the results of a head-to-head trial of Kyprolis versus Velcade which revealed that patients on its drug lived twice as long without their disease worsening.