Amgen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted positive opinions recommending marketing authorization for: Kyprolis (carfilzomib) in combination with lenalidomide and
dexamethasone for the treatment of adult patients with multiple myeloma
who have received at least one prior therapy. BLINCYTO® (blinatumomab) as a conditional marketing authorization for the treatment of adults with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL).
Kyprolis is a proteasome inhibitor for use in the treatment of
patients with relapsed multiple myeloma. Proteasomes play an important
role in cell function and growth by breaking down proteins that are
damaged or no longer needed. Kyprolis blocks proteasomes, which leads 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.
BLINCYTO is the first clinical validation of the bispecific T cell engager (BiTE®) platform, an innovative approach that can help the body's own immune system fight cancer.
The CHMP positive opinions will now be reviewed by the European Commission and if granted, the two products will have marketing authorization in the 28 member countries of the European Union (EU), as well as Iceland, Lichtenstein and Norway.
