Amgen's ($AMGN) hoping its blood cancer med Kyprolis can win an FDA bump-up from third-line treatment to second-line, and it won't have to wait long to find out whether its hopes pay off.
The agency fast-tracked Amgen's application for the new use, which should give Amgen an answer by July 26, the company said. If Kyprolis passes muster, the second-line nod will open up a larger patient population that stays on treatment for a longer period of time. Read: bolstered sales.
That's something the California biotech could definitely use as Kyprolis continues to trail behind Celgene's ($CELG) rival drug Pomalyst. Despite Kyprolis' 8-month-head start, Pomalyst has been trouncing the Amgen drug in the sales department. Kyprolis' performance has raised more than a couple of eyebrows among industry-watchers, especially considering the $10.4 billion Amgen paid to acquire its maker, Onyx Pharmaceuticals, in 2013.
Whether Kyprolis can win that coveted second-line status depends on how regulators view its Phase III ASPIRE data. In that trial, adding Kyprolis to a combo of Celgene's Revlimid and the standard chemotherapy dexamethasone extended progression-free survival to 26.3 months from 17.6 months. The three-drug combo also took the overall response rate to 87%, from 67% among patients using Revlimid and dexamethasone. Three times as many patients showed a complete response to the three-drug cocktail, Amgen said last December, and the regimen also hit secondary endpoints in duration of response and health-related quality of life.
Since then, Amgen has come up with more data that could support second-line use--and eventually help it make a case for first-line treatment. Earlier this month, Amgen said that patients with relapsed multiple myeloma who received Kyprolis and dexamethasone chemotherapy lived for a median 18.7 months without their disease worsening, compared with Takeda's Velcade, which kept disease progression at bay for a median of 9.4 months.
- read Amgen's release
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