Amgen (NASDAQ: AMGN) today 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).
"We are pleased to receive positive CHMP opinions for Kyprolis and BLINCYTO as this is an important step in providing new treatment options for patients in Europe with rare forms of cancer," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "For patients with multiple myeloma, periods of remission become shorter following each new treatment regimen, underscoring the need for additional treatment options. The results of the ASPIRE study demonstrate that Kyprolis extended the time patients live without their disease progressing. Additionally, there is a critical need for new therapies for patients with relapsed or refractory B-cell precursor 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.