Amgen Inc. — Blincyto EMA EPAR public assessment report (EMEA/H/C/003731, 2015)
Amgen Inc. · 2015 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's assessment of Amgen's BLINCYTO (blinatumomab) for treating Philadelphia chromosome-negative relapsed or refractory B-precursor acute lymphoblastic leukemia resulted in a positive CHMP opinion for marketing authorization. The report details the regulatory process and scientific evaluation of the drug's quality, non-clinical, and clinical aspects.
Key findings — cited to the page
| Orphan medicinal product designation date | 24 July 2009 | BLINCYTO · Europe · p.7 |
| Recommended indication | treatment of adults with Philadelphia chromosome negative relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL) | BLINCYTO · p.11 |
| Indication applied for | treatment of Philadelphia chromosome negative relapsed of refractory B-precursor acute lymphoblastic leukaemia (ALL) | BLINCYTO · p.7 |
| CHMP positive opinion date for Marketing Authorisation | 24 September 2015 | BLINCYTO · p.9 |
| Marketing Authorisation application submission date | 9 October 2014 | BLINCYTO · Europe · p.7 |
| Newly diagnosed adult ALL patients achieving initial CR | 90 % | · p.10 |
| Patients experiencing relapse after initial CR | 50 % | · p.10 |
| median OS | 3 months | · p.10 |
| ALL cases diagnosed annually | 7200 | EU · p.9 |
| Adult ALL cases diagnosed annually (percentage of total EU cases) | 40 % | EU · p.9 |
| Adult ALL cases diagnosed annually (absolute number in EU) | 3000 | EU · p.9 |
| ALL cases diagnosed annually | 6020 | United States · p.9 |
Source: Amgen Inc. ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →