Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to ponatinib for the treatment of adult patients with philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other kinase inhibitors are indicated or T315I-positive Ph+ ALL.

This is written in the approval document as:

ICLUSIG is a kinase inhibitor indicated for the treatment of adult patients with as monotherapy in Ph+ ALL for whom no other kinase inhibitors are indicated or T315I-positive Ph+ ALL.

Citation

Takeda Pharmaceuticals America, Inc. Iclusig (ponatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203469s037lbl.pdf. Revised March 2024. Accessed October 30, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	ABL1 p.T315I, BCR::ABL1	Acute Lymphoid Leukemia	Ponatinib