In the head-to-head trial of 929 patients whose multiple myeloma had relapsed following prior treatment, those who received Kyprolis plus low-dose dexamethasone on average lived 47.6 months.
Earlier published data from the trial called Endeavor demonstrated that patients with the incurable blood cancer who received Kyprolis went significantly longer before the disease worsened than those treated with Velcade, a measure known as progression-free survival (PFS).
The prescribing information label already features the PFS data in which patients who received the Amgen drug went twice as long as those who got Velcade before their disease began to worsen, 18.7 months versus 9.4 months.
"Endeavor is the only (relapsed multiple myeloma) study to demonstrate a survival benefit in a head-to-head comparison with a current standard of care regimen," Amgen research chief Sean Harper said in a statement.
Food and Drug Administration said on Tuesday it had approved Lexicon Pharmaceuticals Inc's oral drug to treat carcinoid syndrome diarrhea, a condition that develops in patients with gastrointestinal tumors.