Blincyto (blinatumomab)
- Region
- 🇪🇺 EU
- Active substance
- blinatumomab
- Company
- Amgen Europe B.V.
- Status
- Authorised
- Therapeutic area
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- CHMP opinion
- Thu 24 Sep 2015
- EU approval
- Mon 23 Nov 2015
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/003731
- ATC
- L01FX07
- Official record
- www.ema.europa.eu
Indication
Blincyto is indicated as monotherapy for the treatment of adults with CD19 positive relapsed or refractory B‑cell precursor acute lymphoblastic leukaemia (ALL). Patients with Philadelphia chromosome-positive B-cell precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors (TKIs) and have no alternative treatment options. Blincyto is indicated as monotherapy for the treatment of adults with Philadelphia chromosome-negative CD19 positive B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. Blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 month or older with Philadelphia chromosome-negative CD19 positive B‑cell precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. Blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 month or older with high-risk first relapsed Philadelphia chromosome-negative CD19 positive B-cell precursor ALL as part of the consolidation therapy (see section 4.2). Blincyto is indicated as monotherapy as part of consolidation therapy for the treatment of adult patients with newly diagnosed Philadelphia chromosome negative CD19 positive B-cell precursor ALL.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.