Amgen, Inc. (NASDAQ:AMGN)’s Kyprolis Receives EC Approval For Extended Indication

Amgen, Inc. (NASDAQ:AMGN)’s Kyprolis Receives EC Approval For Extended Indication

Amgen, Inc. (NASDAQ:AMGN)’s Kyprolis has been cleared by the European Commission to treat adult patients with relapsed cases of multiple myeloma in combination with dexamethasone only. The drug had been approved by EC to treat relapsed multiple myeloma patients when combined with dexamethasone and lenalidomide. As such, the latest development is the second EC approval for Kyprolis in less than a year considering that the first approval came in November 2015.

The extended indication approval for the drug by the EC is based on the Phase 3 head-to-head study of the drug. The study assessed the performance of the combination regimen of Kyprolis plus dexamethasone and combination regimen of bortezomib plus dexamethasone.

Superior outcome

In the Phase 3 study, the combined formulation of Amgen’s drug and dexamethasone was found to double the time that patients who received it lived without progression of their cancer when compared to the patients who received the combined formulation of bortezomib and dexamethasone. The rate of complete response in Kyprolis and dexamethasone formulation was also double that of bortezomib and dexamethasone therapy.

According to Amgen’s VP of R&D, Sean E. Harper, it has been proven that Kyprolis-based treatments have superior outcomes compared to the standard-of-care options in combating multiple myeloma.

The outcome of the Phase 3 trial

During the head-to-head Phase 3 trial of the combined formulation of Amgen’s Kyprolis plus dexamethasone, the time that patients who received the treatment without their cancer progressing was 18.7 months. That compared with 9.4 months in the group of patients who received the combined therapy of bortezomib plus dexamethasone.

But the tolerability profile of the drug plus dexamethasone and bortezomib plus dexamethasone was noticed to be similar during the head-to-head late-stage trial. In terms of side effects, the kind of adverse reactions noted in more than 20% of patients who received Kyprolis-based treatment were diarrhea, anemia, thrombocytopenia, fatigue, pyrexia, nausea, peripheral edema, cough and respiratory tract infection.

Regulatory approvals

Besides the EC, Amgen’s Kyprolis is also approved by the U.S. FDA.