Amgen(AMGN) Prnewswire·2025-01-29 21:01Core Insights - The European Commission has approved BLINCYTO® (blinatumomab) as part of consolidation therapy for adult patients with newly diagnosed Philadelphia chromosome-negative CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) [1][7] - The approval is based on the Phase 3 E1910 clinical trial, which demonstrated that adding BLINCYTO to multiphase consolidation chemotherapy significantly improved overall survival compared to chemotherapy alone [2][3] Company Overview - Amgen is a biotechnology company that discovers, develops, manufactures, and delivers innovative medicines, with a focus on treating serious diseases [9] - The company has been recognized as one of the "World's Most Innovative Companies" and is part of the Dow Jones Industrial Average and Nasdaq-100 Index [10] Industry Context - Acute lymphoblastic leukemia (ALL) is a fast-growing blood cancer, with B-ALL being the most common subtype, constituting approximately 75% of cases in adults [4] - The prevalence of ALL in Europe is estimated at 1.28 persons per 100,000 people [4] Product Information - BLINCYTO is the first globally approved Bispecific T-cell Engager (BiTE®) immuno-oncology therapy, targeting CD19 surface antigens on B cells to enhance the immune response against cancer [5][8] - In the EU, BLINCYTO is indicated for various patient groups, including adults with newly diagnosed Philadelphia chromosome-negative CD19-positive B-ALL as part of consolidation therapy [6][13]