Amgen Inc. (AMGN) and its subsidiary Onyx Pharmaceuticals Inc. Wednesday said the late-stage study of its blood cancer drug Kyprolis failed to meet its main goal of prolonging the overall survival of patients with relapsed and advanced refractory multiple myeloma.
The California-based drug giant said the 315-patient, open-label study evaluated myeloma patients treated with Kyprolis compared to an active control regimen of low-dose dexamethasone, or equivalent corticosteroids, plus optional cyclophosphamide.
The company recorded an increase in the incidence of renal adverse events in patients treated with Kyprolis.
"While it is unfortunate that the FOCUS study did not meet its primary endpoint of overall survival, we believe the results from the recent positive ASPIRE Phase 3 clinical trial will be sufficient to support regulatory submissions around the world," said Pablo Cagnoni, president, Onyx Pharmaceuticals Inc.
Earlier this month, Amgen had reported that Kyprolis met primary endpoint in a late-stage study. The Aspire study showed that Kyprolis in combination with two other drugs helped relapsed multiple myeloma patients live significantly longer compared to standard treatment.
Multiple myeloma is the second most common hematologic cancer that results from an abnormality of plasma cells, usually in the bone marrow. In the US, about 70,000 people have multiple myeloma and around 24,000 new cases are diagnosed annually.
The FDA had granted accelerated approval of Kyprolis for the treatment of patients with multiple myeloma in 2012. Kyprolis is marketed in the US by Onyx Pharmaceuticals. Amgen gained Kyprolis when it bought Onyx Pharmaceuticals last year for $10 billion.
In a separate development, Amgen initiated a voluntary recall of pre-filled syringes of its anemia drug Aranesp due to the potential presence of cellulose and/or polyester particles. The company has recalled nine packaged lots of Aranesp from non-U.S. distributors, wholesalers and a number of hospital pharmacies. The potentially impacted product were distributed outside of the US.
AMGN closed Wednesday's trading at $127.34, up $1.02 or 0.81%, on the Nasdaq. The stock, however, dropped to $2.47 or 1.94% in after-hours trade.
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