Positive CHMP opinion to extend indication of Kyprolis for the treatment of relapsed multiple myeloma
The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion to extend the current indication for Kyprolis ( Carfilzomib ) to include treatment in combination with Dexamethasone alone for adult patients with multiple myeloma who have received at least one prior therapy.
The CHMP positive opinion is based on data from the phase 3 head-to-head ENDEAVOR study in which patients with multiple myeloma treated with Kyprolis plus Dexamethasone achieved superior progression-free survival ( PFS ) of 18.7 months compared to 9.4 months in those receiving Velcade ( Bortezomib ) plus Dexamethasone, ( hazard ratio, HR=0.53; 95% CI: 0.44,0.65 p less than 0.0001 ).
The most common adverse reactions that occurred in greater than 20% of patients in the Carfilzomib arm were anemia, fatigue, diarrhea, thrombocytopenia, nausea, pyrexia, dyspnea, respiratory tract infection, cough and peripheral edema.
The European Commission ( EC ) previously granted marketing authorization for Kyprolis in combination with Lenalidomide and Dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy based on results of the ASPIRE study in November 2015.
The randomized ENDEAVOR ( RandomizEd, OpeN Label, Phase 3 Study of Carfilzomib Plus DExamethAsone Vs Bortezomib Plus DexamethasOne in Patients With Relapsed Multiple Myeloma ) trial of 929 patients evaluated Carfilzomib in combination with low-dose Dexamethasone, versus Bortezomib with low-dose Dexamethasone in patients whose multiple myeloma has relapsed after at least one, but not more than three prior therapeutic regimens.
The primary endpoint of the trial was progression-free survival, defined as the time from treatment initiation to disease progression or death.
Proteasomes play an important role in cell function and growth by breaking down proteins that are damaged or no longer needed. Carfilzomib has been shown to block proteasomes, leading to an excessive build-up of proteins within cells.
In some cells, Carfilzomib can cause cell death, especially in myeloma cells because they are more likely to contain a higher amount of abnormal proteins. ( Xagena )
Source: Amgen, 2016