Amgen Sends FDA, EMA Request to Add Survival Data to Kyprolis Label
Amgen submitted applications to the FDA and EMA to include survival data in the labeling for its myeloma drug Kyprolis.
Data from Amgen’s Phase III head-to-head trial showed Kyprolis cut risk of death 21 percent compared to Velcade (bortezomib) and dexamethasone, a 7.6 month overall survival benefit. The company has submitted an SNDA to the FDA and a variation to the marketing application to the EMA to incorporate that information into the product label.
Amgen further reported adverse events in the updated research occurred at levels consistent with previous trials, with the most common events including nausea, bronchitis, asthenia, back pain, thrombocytopenia and headache. The survival benefit was consistent independent of prior bortezomib therapy.