Amgen`s Biologic Blincyto (blinatumomab) Receives Approval in the U.S.
THOUSAND OAKS, Calif., June 21, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) for the treatment of adults and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%, based on additional data from two Phase 3 studies that were submitted. The approval converts BLINCYTO's accelerated approval to a full approval.
Amgen's Biologic Blincyto (Blinatumomab) Receives Approval in the U.S.
GSK is tapping into WuXi Biologics’ T cell-engaging antibodies in a deal worth as much as $1.5 billion, as the UK drugmaker looks to follow suit of others in the T cell-engager field, which includes Amgen’s marketed cancer drug Blincyto.
A clinical trial that started before the first FDA approval for Blincyto might support a new use for the Amgen therapy in acute lymphoblastic leukemia (ALL).
THOUSAND OAKS, Calif., Dec. 13, 2022 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) will present results from the E1910 randomized Phase 3 trial. This is the first study to demonstrate superior overall survival (OS) with BLINCYTO added to consolidation chemotherapy over current standard of care (multiagent consolidation chemotherapy) in newly diagnosed adult patients with Philadelphia chromosome-negative B-ALL who were measurable residual disease (MRD)-negative following induction and intensification chemotherapy. These results were featured in a press briefing on Monday, Dec. 12 at 8:30 a.m. CT and presented on Tuesday, Dec. 13 at 9 a.m. CT as a late breaking oral presentation (LBA1) at the 64th American Society of Hematology (ASH) Annual Meeting & Exposition in New Orleans.
Amgen's Biologic BLINCYTO (Blinatumomab) Receives Approval in the U.S.
Amgen's Biologic Blincyto (Blinatumomab) Receives Approval in the U.S.
Amgen has reported positive data from the Phase III study of BLINCYTO (blinatumomab) in paediatric patients with high-risk first-relapse B-cell precursor acute lymphoblastic leukaemia (B-ALL).
THOUSAND OAKS, Calif., March 2, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that data from a multicenter, randomized Phase 3 study evaluating the efficacy, safety and tolerability of BLINCYTO® (blinatumomab) compared with consolidation chemotherapy before allogeneic hematopoietic stem cell transplantation (alloHSCT) in pediatric patients with high-risk first-relapse B-cell precursor acute lymphoblastic leukemia (B-ALL) were published in The Journal of the American Medical Association (JAMA).1