Amgen Receives CHMP Positive Opinions For Two New Treatment Options For Patients With Blood Cancer In Europe

Amgen (NASDAQ: AMGN)today announced that the Committee for Medicinal Products for Human Use(CHMP) of the European Medicines Agency (EMA) adopted positive opinionsrecommending marketing authorization for: -- Kyprolis(R) (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(R) (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 BLINCYTOas this is an important step in providing new treatment options for patientsin Europe with rare forms of cancer," said Sean E. Harper, M.D., executivevice president of Research and Development at Amgen. "For patients withmultiple myeloma, periods of remission become shorter following each newtreatment regimen, underscoring the need for additional treatment options.The results of the ASPIRE study demonstrate that Kyprolis extended the timepatients live without their disease progressing. Additionally, there is acritical need for new therapies for patients with relapsed or refractoryB-cell precursor ALL." Kyprolis is a proteasome inhibitor for use in the treatment of patients withrelapsed multiple myeloma. Proteasomes play an important role in cellfunction and growth by breaking down proteins that are damaged or no longerneeded. Kyprolis blocks proteasomes, which leads to an excessive build-up ofproteins within cells. In some cells, Kyprolis can cause cell death,especially in myeloma cells because they are more likely to contain a higheramount of abnormal proteins. BLINCYTO is the first clinical validation of the bispecific T cell engager(BiTE(R) ) platform, an innovative approach that can help the body's ownimmune system fight cancer. The CHMP positive opinions will now be reviewed by the European Commissionand if granted, the two products will have marketing authorization in the 28member countries of the European Union (EU), as well as Iceland,Lichtenstein and Norway.