ICLUSIG ponatinib

Drug Class

Tyrosine kinase inhibitor

Mechanism

Inhibits ABL and mutant BCR-ABL1 (including the T315I mutation) tyrosine kinases, blocking downstream growth pathways in leukemia.

Approved Indication

Treatment of adult patients with chronic, accelerated, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) resistant to other TKIs, or who have the T315I mutation.

What This Means For Patients

ICLUSIG 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 (2012) — Sources
• EMA — Approved (2013) — Sources
• NMPA — Approved (2022) — Sources

Pivotal Clinical Evidence

• PACE — Cortes et al., N Engl J Med 2013 (NCT01207440) — Sources

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204212s025lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/iclusig
• https://www.nmpa.gov.cn/