SCEMBLIX asciminib

Drug Class

STAMP inhibitor

Mechanism

Binds specifically to the myristoyl pocket of ABL kinase (STAMP), inducing an inactive conformation to block BCR-ABL1 proliferation signals.

Approved Indication

Treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP), previously treated with two or more tyrosine kinase inhibitors (TKIs), or adult patients with Ph+ CML-CP with the T315I mutation.

What This Means For Patients

SCEMBLIX 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 (2021) — Sources
• EMA — Approved (2022) — Sources
• NMPA — Approved (2023) — Sources

Pivotal Clinical Evidence

• ASCEMBL — Réa et al., Blood 2021 (NCT03106779) — Sources

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215358s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/scemblix
• https://www.nmpa.gov.cn/