Abecma
Oncology· 1535 cited findings· 2 source documents
Company: Bristol-Myers Squibb Company →
What the regulatory reviews say
Abecma is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD-38 antibody, and have demonstrated disease progression on the last therapy. The marketing authorization application was submitted on 30 April 2020. Abecma received Orphan medicinal product designation on 20 April 2017 and Advanced Therapy Medicinal Product designation on 13 October 2016.
In Study CRB-401, the Overall Response Rate (ORR) was 86%. The median duration of response (DoR) for subjects treated with >50 x 10^6 CAR+ T cells with at least 3 months follow-up was not yet reached. Overall survival (OS) in relapsed/refractory MM patients who received ≥ 3 prior lines of therapy and were refractory to an IMiD and PI was 8 to 13 months. Notable safety findings include neutropenia (91.3%), cytokine release syndrome (81.0%), anaemia (70.7%), and thrombocytopenia (66.8%).
Key figures — cited to the source page
| Overall response rate (ORR) in Study CRB-401 | 86% | Bristol-Myers Squibb Company — Abecma EMA EPAR public assess, p.8 |
| Overall survival (OS) in relapsed/refractory MM patients | 8 to 13 months | Bristol-Myers Squibb Company — Abecma EMA EPAR public assess, p.14 |
| Neutropenia | 91.3% | Bristol-Myers Squibb Company — Abecma EMA EPAR public assess, p.119 |
| Cytokine release syndrome (CRS) | 81.0% | Bristol-Myers Squibb Company — Abecma EMA EPAR public assess, p.119 |
| Anaemia | 70.7% | Bristol-Myers Squibb Company — Abecma EMA EPAR public assess, p.119 |
| Thrombocytopenia | 66.8% | Bristol-Myers Squibb Company — Abecma EMA EPAR public assess, p.119 |
| Marketing authorization application submission date | 30 April 2020 | Bristol-Myers Squibb Company — Abecma EMA EPAR public assess, p.8 |
| Orphan medicinal product designation date | 20 April 2017 | Bristol-Myers Squibb Company — Abecma EMA EPAR public assess, p.8 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.