FDA approves new Kyprolis combination therapy in multiple myeloma

The US Food and Drug Administration has approved the supplemental New Drug Application (sNDA) of Amgen’s Kyprolis (carfilzomib) for injection in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.

The FDA also approved Kyprolis as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. This FDA decision converts to full approval the initial accelerated approval Kyprolis received in July 2012 as a single agent.

Commenting on the announcement, Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, said, “Kyprolis is the only approved therapy for relapsed multiple myeloma with proven efficacy as a single agent, doublet and triplet combination that is offered in a variety of doses to meet individual patient needs. Importantly, this new approval supports the use of Kyprolis as a backbone therapy for the management of relapsed multiple myeloma, a difficult-to-treat blood cancer.”

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. The irreversibility of Kyprolis’ binding has also been shown to offer a more sustained inhibition of the targeted enzymes.

Kyprolis and dexamethasone achieved 50% greater PFS than Velcade and dexamethasone

The latest approval is based on results from the Phase 3 head-to-head ENDEAVOR study. This was a superiority trial in which the primary endpoint was progression-free survival (PFS). The data showed patients with relapsed multiple myeloma treated with Kyprolis and dexamethasone achieved 50% greater PFS of 18.7 months compared to 9.4 months in those receiving Velcade (bortezomib) and dexamethasone. Patients in the study were treated until disease progression.

This new indication for Kyprolis is the second in six months. In July 2015, the FDA approved another expanded indication for Kyprolis in combination with lenalidomide and dexamethasone (KRd) for the treatment of patients with multiple myeloma who have received one to three prior lines of therapy.