FDA Approves Addition of Survival Data to Kyprolis Label for Multiple Myeloma Treatment

The Food and Drug Administration (FDA) approved the supplemental New Drug Application to add to the U.S. Prescribing Information for Kyprolis (carfilzomib) for the treatment of patients with relapsed or refractory multiple myeloma.

The supplemental New Drug Application was intended to add the positive overall survival (OS) data from the phase 3 ASPIRE trial, published in the Journal of Clinical Oncology, which showed that the addition of Kyprolis to Revlimid (lenalidomide) and dexamethasone — a combination referred to as KRd – reduced the risk of death by 21 percent and extended OS by 7.9 months compared to Revlimid plus dexamethasone (Rd) in patients with relapsed or refractory myeloma who had three or more prior therapies.

“The ASPIRE trial showed significant improvement in survival in patients with relapsed or refractory multiple myeloma who received Kyprolis as a part of a triplet regimen. With this approval, the U.S. Prescribing Information for Kyprolis now includes positive overall survival data from two phase 3 trials, underscoring the important role of proteasome inhibition in the treatment of multiple myeloma,” David M. Reese, M.D., senior vice president of Translational Sciences and Oncology at Amgen, said in a press release.

Kyprolis was initially granted FDA approval in 2012, and, according to Amgen, the manufacturer of the drug, has treated about 80,000 patients across the globe. It is currently approved for use in combination with dexamethasone or with Revlimid plus dexamethasone for patients with relapsed or refractory multiple myeloma who previously had one to three prior lines of therapy. It is also approved to be used as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who had at least one prior line of therapy.

The drug works by blocking proteasomes, which leads to an excessive amount of proteins within the cell. Since myeloma cells are more likely to have a higher number of abnormal proteins, this mechanism of action can lead to cell death.

Safety data from the ASPIRE trial were consistent with previous findings. The most common side effects of the drug combination, which affected 20 percent or more of patients, included diarrhea, anemia, neutropenia, fatigue, upper respiratory tract infection, pyrexia, cough, hypokalemia (low levels of potassium in the blood), thrombocytopenia, muscle spasms, pneumonia, nasopharyngitis, nausea, constipation, insomnia and bronchitis.

When used as a single agent, common side effects of Kyprolis seen in clinical trials include low red blood cell count, fatigue, low platelets, nausea, fever, difficulty breathing, diarrhea, headache, cough and swelling of lower legs or hands.