01/26/2021

New Indication in a CML Therapy

A new indication in a CML therapy by Takeda

ICLUSIG is now FDA-approved for the treatment of adult patients with chronic phase
(CP-) chronic myeloid leukemia (CML) with resistance or intolerance to at least 2 prior TKIs. The dosing strategy and safety profile have also been updated.1

ICLUSIG is now FDA-approved for the treatment of adult patients with chronic phase (CP-) chronic myeloid leukemia (CML) with resistance or intolerance to at least 2 prior TKIs. The dosing strategy and safety profile have also been updated.1

OPTIC examined a response-based dosing strategy in a TKI-resistant population of patients with CP-CML. Patients received one of three starting dosages: 45 mg, 30 mg, or 15 mg once daily. Patients who received a starting dose of 45 mg or 30 mg had a dose reduction to 15 mg once daily upon achieving ≤1% BCR‑ABL1 IS . The recommended starting dose for patients with CP‑CML is 45 mg once daily with a reduction to 15 mg once daily upon achievement of ≤1% BCR‑ABL1IS. 1

BCR-ABL1IS=BCR-ABL international scale; TKI=tyrosine kinase inhibitor.

 
INDICATIONS
ICLUSIG is a kinase inhibitor indicated for the treatment of adult patients with:
• Chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors.
 
• Accelerated phase (AP) or blast phase (BP) CML or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other kinase inhibitors are indicated.
 
• T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ ALL.
 
Limitations of Use:
ICLUSIG is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML.
 
Please see the Important Safety Information, including Boxed Warning, below.

WARNING: ARTERIAL OCCLUSIVE EVENTS, VENOUS THROMBOEMBOLIC EVENTS, HEART FAILURE, and HEPATOTOXICITY
See full prescribing information for complete boxed warning.

• Arterial occlusive events (AOEs), including fatalities, have occurred in ICLUSIG-treated patients. AOEs included fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures. Patients with and without cardiovascular risk factors, including patients age 50 years or younger, experienced these events. Monitor for evidence of AOEs. Interrupt or discontinue ICLUSIG based on severity. Consider benefit-risk to guide a decision to restart ICLUSIG.
 
• Venous thromboembolic events (VTEs) have occurred in ICLUSIG-treated patients. Monitor for evidence of VTEs. Interrupt or discontinue ICLUSIG based on severity.
 
• Heart failure, including fatalities, occurred in ICLUSIG-treated patients. Monitor for heart failure and manage patients as clinically indicated. Interrupt or discontinue ICLUSIG for new or worsening heart failure.
 
• Hepatotoxicity, liver failure and death have occurred in ICLUSIG-treated patients. Monitor liver function tests. Interrupt or discontinue ICLUSIG based on severity.
 

https://www.iclusig.com/pdf/ICLUSIG-Prescribing-Information.pdf