Kyprolis (carfilzomib), when given with dexamethasone, lets relapsed myeloma patients live an average 7.6 months longer than those treated with Velcade (bortezomib) with dexamethasone — information that Amgen, which makes Kyprolis, hopes to include in the treatment’s prescription label.
The company has applied to both the U.S. Food and Drug Administration and the European Medicines Agency for permission to change the label for Kyprolis.
“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,” Dr. Sean E. Harper, Amgen’s executive vice president of R&D, said in a press release. “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.”
Amgen presented its results earlier this year at the two scientific meetings, the 16th International Myeloma Workshop in New Delhi, India, and the 22nd Congress of the European Hematology Association in Madrid.
The data supporting the move came from the Phase 3 ENDEAVOR clinical trial (NCT01568866) comparing the two drug combinations. The trial included patients who had relapsed after one to three earlier treatment courses.
The newly submitted data showed that the Kyprolis-dexamethasone combo reduced risk of death by 21 percent compared to Velcade and dexamethasone.
The median overall survival was 47.6 months with Kyprolis and 40 months with Velcade, with no significant difference in survival between patients who had earlier been exposed to Velcade and those who had not.
In 2012, the FDA approved Kyprolis for advanced myeloma that has progressed despite treatment with Velcade and an immunomodulatory drug. Three years later, it expanded that approval to include a combination with Revlimid (lenalidomide) and dexamethasone, to treat patients with relapsed multiple myeloma who have previously received at least one prior treatment.
In January 2016, another expansion was approved to include combinations with dexamethasone or Revlimid (lenalidomide) plus dexamethasone in relapsed or treatment refractory myeloma patients.