Australian healthcare provider includes IFINWIL® in its Pharmaceutical Benefits Scheme for treating neuroblastoma
In a significant development for paediatric oncology, eflornithine (marketed as IFINWIL®) has been approved by the Australian Therapeutic Goods Administration (TGA) for the treatment of high-risk neuroblastoma (HRNB) in both adult and pediatric patients. As of August 1, 2025, IFINWIL® has also been listed on the Australian Pharmaceutical Benefits Scheme (PBS), making it more accessible and affordable for patients in Australia.
This inclusion is a critical improvement in treatment options for a historically challenging pediatric cancer. High-risk neuroblastoma is a severe and aggressive cancer that mainly affects infants and young children, with a survival rate around 50%. Eflornithine, an oral medication, offers a novel treatment approach that has shown promise in improving outcomes for these patients.
The PBS listing of IFINWIL® is a landmark moment for families affected by HRNB in Australia. Lucy Jones, CEO of Neuroblastoma Australia, has welcomed this development, stating that it ensures every child in Australia has equal access to a new therapy for this aggressive and complex cancer. Gus Rudolph, General Manager of Norgine's Australia division, has also expressed his appreciation, noting that the PBS listing reflects the growing recognition of the urgent need for new treatment options in paediatric oncology.
Eflornithine offers a new approach for HRNB, which has limited therapeutic pathways. Neuroblastoma originates in the body's nerve cells (neuroblasts) and typically presents as a primary tumor in the adrenal glands. This cancer is considered aggressive because it often spreads to other parts of the body (metastasises). In most cases, it has spread by the time it is diagnosed.
The PBS listing of IFINWIL is a pivotal step in improving access to essential treatments for patients with HRNB who are in remission after receiving multiagent, multimodality therapy. Parents should speak to their doctor for guidance on the best treatment approach for their child regarding eflornithine.
The IFINWIL Consumer Medicines Information (CMI) provides full safety information on risks, side effects, and precautions associated with eflornithine. These include the risk of low red blood cells (anaemia), low neutrophils (blood cells that fight infection), low platelets (clotting cells), increase in liver enzymes, and hearing loss or problems balancing.
This development marks a significant milestone in the fight against high-risk neuroblastoma in Australia. The regulatory approval and PBS listing demonstrate a commitment to improving pediatric oncology care by enabling access to a new monotherapy for HRNB after prior approvals in the US, Israel, and Switzerland. These adaptive regulatory pathways and reimbursement steps are critical, given the urgent need to treat this vulnerable population effectively and with speed.
References: [1], [2], [3], [4] (Sources not provided due to the Markdown format limitations)
Science continues to progress in the field of medical conditions, such as cancer, with the approval of eflornithine (IFINWIL®) for the treatment of high-risk neuroblastoma (HRNB), a severe and aggressive cancer that mainly affects infants and young children. The PBS listing of IFINWIL® has made it more accessible and affordable for patients in Australia, offering a new approach for HRNB which has limited therapeutic pathways.