Name

Ponatinib

Alternate Names

Iclusig

Abbreviations

None

Category

Chemotherapy

Subcategory

kinase inhibitor

NSC Number

None

Primary Site

CML
Chronic myeloid leukemia
Ph+ALL
Philadelphia-chromosome positive acute lymphoblastic leukemia
Acute lymphoblastic leukemia
ALL

Histology

None

Remarks

March 22, 2024 FDA granted accelerated approval to Iclusig (ponatinib) with chemotherapy for adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

March 19, 2024 Following FDA request to suspend marketing of ponatinib (Iclusig) October 2013, this drug has now
received accelerated approval with chemotherapy for adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

Ponatinib received FDA approval December 14, 2012.

Important note October 31, 2013: The FDA has asked the manufacturer of Iclusig to suspend marketing and sales of the drug because of life-threatening blood clots and severe narrowing of blood vessels.

December 12, 2016: Ponatinib received full FDA approval for treatment of adult patients with chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (ALL).

Coding

This drug should be coded
Glossary