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Amgen seeks US & European regulatory approval to include overall survival data in Kyprolis label

Thousand Oaks, California
Monday, July 17, 2017, 18:00 Hrs  [IST]

Amgen has announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) and a variation to the marketing application to the European Medicines Agency (EMA) to include overall survival (OS) data from the phase 3 head-to-head ENDEAVOR trial in the product information for Kyprolis (carfilzomib).

Data submitted to regulatory authorities showed that Kyprolis, administered at the 56 mg/m2 dose as a 30-minute infusion twice weekly with dexamethasone (Kd56), reduced the risk of death by 21 percent over Velcade (bortezomib) and dexamethasone (Vd), resulting in a 7.6 month OS benefit (median OS 47.6 months for Kd56 versus 40.0 months for Vd, HR=0.79; p=0.01). The OS benefit was consistent regardless of prior bortezomib therapy (HR 0.75 for no prior Velcade; HR 0.84 for prior Velcade). These results were presented earlier this year at the 16th International Myeloma Workshop and the 22nd Congress of the European Hematology Association.

"Kyprolis is the first-and-only multiple myeloma therapy to demonstrate superior overall survival in a head-to-head comparison with a current standard of care, extending survival by 7.6 months over Velcade," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We submitted these important data to regulatory authorities in the US and Europe because we know that Kyprolis may offer appropriate multiple myeloma patients a better chance for a longer life at first relapse compared to Velcade when added to dexamethasone."

Since its approval in 2012, Kyprolis has been prescribed to more than 50,000 patients worldwide. The Kyprolis clinical program continues to focus on providing solutions for physicians and patients in treating this frequently relapsing and difficult-to-treat cancer. Kyprolis is available for patients whose myeloma has relapsed or become resistant to another treatment and continues to be studied in a range of combinations and patient populations.

Adverse events observed in this updated analysis were consistent with those previously reported for ENDEAVOR. The most common adverse events (greater than or equal to 20 percent) in the Kyprolis arm were anemia, diarrhea, pyrexia, dyspnea, fatigue, hypertension, cough, insomnia, upper respiratory tract infection, peripheral edema, nausea, bronchitis, asthenia, back pain, thrombocytopenia and headache.

 

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