VANFLYTA quizartinib

Drug Class

FLT3 kinase inhibitor

Mechanism

Selectively inhibits FLT3 receptor tyrosine kinase, blocking cell proliferation and signaling in FLT3-ITD mutant myeloid leukemia.

Approved Indication

In combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy, and as maintenance monotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive.

What This Means For Patients

Vanflyta (quizartinib) is an oral receptor tyrosine kinase inhibitor targeted for adult patients with newly diagnosed acute myeloid leukemia (AML) harboring FLT3-ITD mutations. It is administered alongside chemotherapy. It is available under the special-import policy in the Hainan Boao Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2023) — label
• PMDA — approved (2019) — source
• EMA — approved (2023) — source
• NMPA — approved (2024) — source

Pivotal Clinical Evidence

• QuANTUM-First — Erba et al., Lancet 2023 (NCT02668653) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216951s000lbl.pdf
• https://www.pmda.go.jp/
• https://www.ema.europa.eu/en/medicines/human/EPAR/vanflyta
• https://www.nmpa.gov.cn/