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 (ponatinib) is a potent targeted kinase inhibitor designed for patients with chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). It is specifically effective against the T315I gatekeeper mutation. It is available under the special-import policy in the Hainan Boao Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2012) — label
• EMA — approved (2013) — source
• NMPA — approved (2022) — source

Pivotal Clinical Evidence

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

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/