Patients in Europe with multiple myeloma could soon get access to a new treatment option for their disease following approval of Amgen’s Kyprolis, the first irreversible proteasome inhibitor cleared to treat the blood cancer.
Kyprolis (carfilzomib) has been green-lighted for use in combination with Celgene’s multiple myeloma therapy Revlimid (lenalidomide) and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
"Multiple myeloma is a complex blood cancer that often becomes resistant to treatment, which is why there is a need for new therapeutic options that provide deep and durable responses to extend the time patients live without their disease progressing,” said Sean Harper, vice president of R&D at Amgen.
In clinical studies, around a third of patients achieved a complete response or better on the Kyprolis-based regimen, “which is three times more frequent than in the lenalidomide and dexamethasone arm,” said Meletios A. Dimopoulos, Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine. “In addition, the regimen provided patients with more than two years without disease progression”.
European approval of the drug was based on data from the pivotal Phase III ASPIRE trial, in which patients given the Kyprolis/Revlimid/dexamethasone combo had median progression-free survival of 26.3 months compared to 17.6 months for those treated with just Revlimid and dexamethasone.
Around 39,000 patients are diagnosed with multiple myeloma in Europe each year and 24,000 patient deaths are reported on an annual basis, Amgen noted.