A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia in Adults
Latest Information Update: 08 Aug 2024
At a glance
- Drugs Blinatumomab (Primary) ; Cyclophosphamide; Cyclophosphamide; Cytarabine; Cytarabine; Cytarabine; Daunorubicin; Dexamethasone; Etoposide; Mercaptopurine; Methotrexate; Methotrexate; Methotrexate; Pegaspargase; Pegaspargase; Prednisone; Rituximab; Vincristine
- Indications Precursor B-cell lymphoblastic leukaemia-lymphoma; Precursor cell lymphoblastic leukaemia-lymphoma
- Focus Registrational; Therapeutic Use
- 06 Aug 2024 According to an Amgen media release, data from this study published in the New England Journal of Medicine.
- 14 Jun 2024 According to an Amgen media release, the U.S. Food and Drug Administration (FDA) has approved BLINCYTO (blinatumomab) for the treatment of adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase, regardless of measurable residual disease (MRD) status based on results form E1910 trial.
- 06 Feb 2024 According to an Amgen media release, The FDA granted Priority Review for the Company's supplemental BLA for BLINCYTO in early-stage, CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) based in part on the Phase 3 E1910 study.Based on the Priority Review designation, the PDUFA date for BLINCYTO is June 21, 2024. Additional global regulatory authority submissions are underway.