EU approves Kyprolis (carfilzomib) + Revlimid (lenalidomide) + dexamethasone to treat multiple myeloma.- Amgen

Amgen has announced the European Commission (EC) granted marketing authorization for Kyprolis (carfilzomib) in combination with Revlimid (lenalidomide) and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. Kyprolis is the first irreversible proteasome inhibitor approved in the European Union (EU) for use in combination treatment of patients with relapsed multiple myeloma.

The EC approved Kyprolis based on data from the pivotal Phase III ASPIRE (CArfilzomib, Lenalidomide, and DexamethSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) trial. The study showed that patients treated with Kyprolis in combination with Revlimid (lenalidomide) and dexamethasone (regimen referred to as KRd) had increased median time to progressive disease (PD) or death by 8.7 months compared to patients treated with lenalidomide and dexamethasone (regimen referred to as Rd). The median progression-free survival (PFS) was 26.3 months in the KRd arm compared to 17.6 months in the Rd arm (HR: 0.69; 95 percent CI: 0.57 to 0.83; p=0.0001).

The most common adverse events (AEs) in the Kyprolis arm included pneumonia (1 percent), myocardial infarction (0.8 percent) and upper respiratory tract infection (0.8 percent). Discontinuation of treatment due to AEs occurred in 15 percent of patients in the KRd arm versus 18 percent of patients in the Rd arm.

Comment: Amgen plans to submit data from the Phase III ENDEAVOR (RandomizEd, OpeN Label, Phase III Study of Carfilzomib Plus DExamethAsone Vs Bortezomib Plus Dexamethas in Patients With Relapsed Multiple Myeloma) trial for potential authorization of Kyprolis in combination with dexamethasone in the EU. This data also serves as the basis of the supplemental New Drug Application of Kyprolis in combination with dexamethasone for patients with relapsed multiple myeloma, which has been accepted for priority review by the FDA.