About IWILFIN

IWILFIN and Relapse Reduction

IWILFIN was assessed in Study 3b, a clinical trial examining its safety and efficacy in 105 pediatric patients with high-risk neuroblastoma. All patients received IWILFIN twice daily for up to 2 years after achieving remission from upfront therapy.

To better interpret the outcomes of Study 3b, its results were compared to an external control database of similar high-risk neuroblastoma patients from another trial—Study ANBL0032, which studied pediatric patients who also achieved remission after upfront treatment but who did not go on to receive IWILFIN.

52 Percent Reduced Risk Removebg Preview

In the externally controlled study, patients who received IWILFIN had a 52% reduced risk of relapse.

The primary endpoint of this study was event free survival, defined as no disease progression, relapse, secondary cancer, or death due to any cause. In supplementary analyses, the reduced risk of relapse for patients taking IWILFIN ranged from 57% to 41%.

68 Percent Reduced Risk Death Removebg Preview

In the externally controlled study, patients who received IWILFIN had a 68% reduced risk of death.

The secondary endpoint of this study was overall survival, defined as death due to any cause. In supplementary analyses, the reduced risk of death for patients taking IWILFIN ranged from 71% to 55%.

IWILFIN Side Effects

In clinical studies, IWILFIN was generally well tolerated and side effects were manageable.

Hearing loss is common during treatment with IWILFIN and can be serious. During clinical trials, hearing loss was sometimes reversible by adjusting the IWILFIN dosage
IWILFIN could cause low blood counts and failure of bone marrow to make enough platelets, red blood cells, or white blood cells. Blood count monitoring will occur before starting and during treatment with IWILFIN
IWILFIN could cause liver problems. Blood tests to monitor liver function will occur before starting and during treatment with IWILFIN

Side Effect	Percentage
Hearing Loss	11%
Ear Infection	10%
Fever	7%
Pneumonia	5%
Diarrhea	5%

Side Effects in IWILFIN Clinical Trials (N=360)*

*Pooled safety population (N=360) reflects patients in Study 3b and another IWILFIN trial, Study 14

There are no contraindications for IWILFIN

How IWILFIN Works in High-Risk Neuroblastoma

IWILFIN is a targeted therapy that disrupts the polyamine pathway that plays a role in tumor growth and development.

Also known as DFMO (difluoromethylornithine), IWILFIN works by blocking an enzyme called ornithine decarboxylase (ODC). ODC is responsible for producing polyamines (PAs), which are important to tumor formation and growth.

Without IWILFIN

With IWILFIN

Learn more about IWILFIN by watching the video below.

Discover how IWILFIN works, why it’s needed, how it was studied, and the potential side effects—all in one short, easy-to-understand video. Because when you understand the “why” behind the treatment, you can feel more confident in the journey ahead.

Starting IWILFIN

Explore what support is available to you and your child when taking IWILFIN.

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