The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given marketing authorization for Amgen’s two new treatment options for patients with blood cancer.
Kyprolis (carfilzomib) in combination with lenalidomide and dexamethasone is indicated to treat adult patients with multiple myeloma who have received at least one prior therapy.
BLINCYTO (blinatumomab) can be used for the treatment of adults with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL).
Kyprolis blocks proteasomes, which results in an excessive build-up of proteins within cells.
The EMA granted orphan drug designation to the drug in 2008, and in February this year, it granted accelerated assessment to its marketing authorization application.
Amgen said BLINCYTO is the first clinical validation of the bispecific T cell engager (BiTE) platform, a new approach that can help the body’s own immune system fight cancer.
The European Commission will review the CHMP positive opinions. If approved, both the products will have marketing authorization in the 28 member countries of the European Union, as well as Iceland, Lichtenstein and Norway.
Amgen executive vice president of research and development Sean Harper said: “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.
“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.”
Published 28 September 2015