Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ABL1 p.T315I, BCR::ABL1 status confers therapeutic sensitivity to Ponatinib in patients with Acute Lymphoid Leukemia.
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 statement is based on a regulatory approval from the Food and Drug Administration:
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.