Vanflyta(quizartinib)
Oncology· 585 cited findings· 1 source document
Company: Daiichi Sankyo Company, Limited
What the regulatory reviews say
Vanflyta (quizartinib) is a drug that received a positive opinion for marketing authorisation on 14 September 2023. It was granted orphan medicinal product designation (EU/3/09/622) on 23 March 2009, which was subsequently withdrawn on 19 September 2023. The recommended starting dose with strong CYP3A inhibitors is 17.7 mg, and the recommended continuation dose is 26.5 mg.
In terms of efficacy, the hazard ratio for overall survival (quizartinib vs placebo) was 0.790. For subjects undergoing HSCT in the 60 mg group, efficacy was 42.1%. The composite complete remission (CRc) rate overall was 47.4%, with a median time to CRc of 4.5 weeks. FLT3 phosphorylation inhibition was 99.2% with 60 mg quizartinib in ITD+ cells. Complete remission (CR) rates for induction chemotherapy ranged from 60 to 85% for patients <=60 years and 40 to 60% for patients >60 years.
Regarding safety, the median model-predicted change from baseline of QTcF at Cmax,ss was 24.1 ms for the 60 mg dose. Early deaths within 60 days were 20 in the quizartinib arm compared to 13 in the placebo arm. Non-relapse mortality associated with allo-HSCT was as high as 20%.
Key figures — cited to the source page
| Hazard ratio for OS (quizartinib vs placebo) | 0.790 | Daiichi Sankyo Company, Limited — Vanflyta EMA EPAR public a, p.46 |
| Efficacy (Subjects undergoing HSCT, 60 mg group) | 42.1 | Daiichi Sankyo Company, Limited — Vanflyta EMA EPAR public a, p.53 |
| Composite complete remission (CRc) rate (overall) | 47.4 | Daiichi Sankyo Company, Limited — Vanflyta EMA EPAR public a, p.52 |
| Median time to CRc (overall) | 4.5 | Daiichi Sankyo Company, Limited — Vanflyta EMA EPAR public a, p.52 |
| FLT3 phosphorylation inhibition (60 mg quizartinib, ITD+ cells) | 99.2 | Daiichi Sankyo Company, Limited — Vanflyta EMA EPAR public a, p.50 |
| Median model-predicted change from baseline of QTcF at Cmax,ss (60 mg) | 24.1 | Daiichi Sankyo Company, Limited — Vanflyta EMA EPAR public a, p.51 |
| Early deaths (within 60 days) in quizartinib arm | 20 | Daiichi Sankyo Company, Limited — Vanflyta EMA EPAR public a, p.73 |
| Marketing authorisation positive opinion date | 14 September 2023 | Daiichi Sankyo Company, Limited — Vanflyta EMA EPAR public a, p.11 |
Source documents
Explore the full evidence
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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.