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 is not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• FDA — Approved (2023) — Sources
• PMDA — Approved (2019) — Sources
• EMA — Approved (2023) — Sources
• NMPA — Approved (2024) — Sources

Pivotal Clinical Evidence

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

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/