Besponsa
Oncology· 529 cited findings· 2 source documents
Company: Pfizer Inc. →
What the regulatory reviews say
Besponsa is indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The marketing authorization application was submitted on 14 April 2016, and the drug received orphan medicinal product designation on 7 June 2013. Approval for adults with R/R BCP-ALL was granted on 17 August 2017, 29 June 2017, 10 July 2017, and 19 January 2018 across different regulatory bodies.
In clinical trials, Besponsa demonstrated a Haematological remission (CR/CRi by EAC in ITT population) of 80.7%. The Overall Response Rate (CR+CRi+CRp) was 78.6%. The median Duration of Response (DoR) ranged from 6.9 months to 13.9 months across different analyses, with a median of 8.0 months in one assessment. The median Event-Free Survival (EFS) was 7.3 months, with an EFS rate at Month 6 of 55.3% and at Month 12 of 29.8%. The recommended total dose for the first cycle is 1.8 mg/m2, and for subsequent cycles (CR/CRi) is 1.5 mg/m2.
Regarding safety, the cumulative incidence rate of non-relapse mortality at Month 24 ranged from 8.50% to 21.43%. Other assessments of cumulative incidence rate of non-relapse mortality ranged from 3.33% to 21.43%.
Key figures — cited to the source page
| Haematological remission (CR/CRi by EAC in ITT population) | 80.7 | Pfizer Inc. — Besponsa EMA EPAR public assessment report (EM, p.129 |
| Overall Response Rate (CR+CRi+CRp) | 78.6 | Pfizer Inc. — Besponsa EMA EPAR variation assessment report, p.11 |
| Median Duration of Response (DoR) | 8.0 | Pfizer Inc. — Besponsa EMA EPAR variation assessment report, p.12 |
| Median Event-Free Survival (EFS) | 7.3 | Pfizer Inc. — Besponsa EMA EPAR variation assessment report, p.13 |
| Cumulative incidence rate of non-relapse mortality at Month 24 | 8.50 | Pfizer Inc. — Besponsa EMA EPAR variation assessment report, p.19 |
| Recommended total dose of BESPONSA for first cycle | 1.8 | Pfizer Inc. — Besponsa EMA EPAR public assessment report (EM, p.11 |
| Approval date for adults with R/R BCP-ALL | 17 August 2017 | Pfizer Inc. — Besponsa EMA EPAR variation assessment report, p.6 |
| Orphan medicinal product designation date | 7 June 2013 | Pfizer Inc. — Besponsa EMA EPAR public assessment report (EM, p.7 |
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.