Human therapeutics company Amgen (NASDAQ:AMGN) reported on Wednesday the receipt of approval from the US Food and Drug Administration (FDA) to add the supplemental New Drug Application (sNDA) to the overall survival (OS) data for KYPROLIS (carfilzomib) for relapsed or refractory multiple myeloma.

The company said the additional data from the Phase 3 head-to-head ENDEAVOR trial to the label demonstrated that KYPROLIS and dexamethasone (Kd) reduced the risk of death by 21% and increased OS (overall survival) by seven and half months versus Velcade (bortezomib) and dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma, an incurable blood cancer.

In conjunction, the randomized ENDEAVOR trial of 929 patients evaluated KYPROLIS in combination with low-dose dexamethasone, versus Velcade with low-dose dexamethasone in relapsed or refractory patients who previously received at least one, but not more than three, prior therapeutic regimens. The study was conducted at 235 sites worldwide, added the company.

According to the company, the primary endpoint of the trial was progression-free survival, defined as the time from treatment initiation to disease progression or death.

Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed. KYPROLIS has been shown to block proteasomes, leading to an excessive build-up of proteins within cells. In some cells, KYPROLIS can cause cell death, especially in myeloma cells because they are more likely to contain a higher amount of abnormal proteins, concluded the company.