Amgen receives positive CHMP opinion to extend indication of Kyprolis
Posted: 27 May 2016 | | No comments yet
The CHMP has adopted a positive opinion to extend the indication for Kyprolis to include treatment in combination with dexamethasone in multiple myeloma…
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion to extend the current indication for Amgen’s 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 III 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.
Commenting on the news, Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, said: “We are pleased that the CHMP has recognized these robust data with a positive opinion, and we look forward to ensuring approval of this extended indication of Kyprolis.”
The CHMP positive opinion will now be reviewed by the European Commission (EC) and if granted, the marketing authorisation will be extended to include Kyprolis in combination with dexamethasone in the 28 member countries of the European Union, as well as Iceland, Lichtenstein and Norway. The extended indication adopted by the CHMP is: Kyprolis in combination with either lenalidomide and dexamethasone or dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
The EC previously granted marketing authorisation 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. Today’s CHMP positive opinion follows the US Food and Drug Administration’s approval of a supplemental New Drug Application based on the ENDEAVOR results in January 2016.