AMGEN — Blincyto FDA Review (NDA/BLA 125557, 2020)
Amgen Inc. · 2020 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved Amgen's Blincyto (blinatumomab) in 2018 for treating B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) >= 0.1% in adults and children. This accelerated approval, based on trials like MT103-203 showing high MRD complete response rates and improved relapse-free survival, requires confirmatory studies. Blincyto's administration guidelines, including dose modifications and reconstitution, are critical due to risks like Cytokine Release Syndrome (CRS) and neurological toxicities. The REMS program mitigates these risks, with updated safety information and hospitalization recommendations. Efficacy was also demonstrated in relapsed/refractory ALL.
Key findings — cited to the page
| Grade 3 or higher neurological toxicities incidence | 13 % | BLINCYTO · p.26 |
| Grade 3 or greater elevations in liver enzymes incidence (outside CRS) | 7 % | BLINCYTO · p.27 |
| Back pain incidence (any grade) | 12 % | BLINCYTO · p.30 |
| Decreased immunoglobulins incidence (Grade 3+) | 5 % | BLINCYTO · p.29 |
| Hypertransaminasemia incidence (Grade 3+) | 7 % | BLINCYTO · p.30 |
| Encephalopathy incidence (any grade) | 10 % | BLINCYTO · p.30 |
| Encephalopathy incidence (Grade 3+) | 4 % | BLINCYTO · p.30 |
| Insomnia incidence (any grade) | 18 % | BLINCYTO · p.30 |
| Aphasia incidence (any grade) | 12 % | BLINCYTO · p.30 |
| Hypertransaminasemia incidence (any grade) | 9 % | BLINCYTO · p.30 |
| Dizziness incidence (any grade) | 10 % | BLINCYTO · p.30 |
| Adverse reactions of Grade 3 or higher incidence | 64 % | BLINCYTO · p.29 |
Source: Amgen Inc. ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →