Iwilfin (eflornithine) / US WorldMeds, Norgine - LARVOL DELTA

Curant Rare Announces Exclusive Pharmacy Partnership for IWILFIN, the First and Only FDA-Approved Oral Maintenance Therapy Shown to Cut the Risk of High-Risk Neuroblastoma Relapse in Half (Businesswire) - "Beginning in August 2025, patients will transition to Curant Rare with one clear goal in mind: to ensure uninterrupted access to care while enhancing the patient and caregiver experience through the IWILFIN Cares program."

Licensing / partnership • Neuroblastoma

Norgine welcomes PBS listing in Australia of IFINWIL (eflornithine) for patients with high-risk neuroblastoma (HRNB) (PRNewswire) - "Norgine, announced today the inclusion of IFINWIL (eflornithine) on Australia's Pharmaceutical Benefits Scheme (PBS). This listing comes just 3 months after receiving registration by the Therapeutic Goods Administration (TGA) and represents a pivotal step in improving access to essential treatments for patients with high-risk neuroblastoma (HRNB) who are in remission after receiving multiagent, multimodality therapy."

Reimbursement • Neuroblastoma

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 July 2025 (European Medicines Agency) - "Withdrawal of applications: Ifinwil (eflornithine), for the treatment of adults and children from one year of age with high-risk neuroblastoma, a cancer of nerve cells in different parts of the body."

European regulatory • Neuroblastoma

Swissmedic approves IFINWIL (eflornithine) for children diagnosed with high-risk neuroblastoma (HRNB) (PRNewswire) - "Norgine...is pleased to announce that Swissmedic has approved the registration of IFINWIL (eflornithine) as monotherapy for the treatment of paediatric patients from one year with high-risk neuroblastoma (HRNB)....This milestone marks a further regulatory approval of IFINWIL for high-risk neuroblastoma, following approvals in the US, Israel and Australia....'By collaborating with international regulatory partners through Project Orbis, we are advancing our strategy to broaden access to innovative therapies for paediatric patients in Europe and ANZ'."

Approval • Project Orbis • Neuroblastoma

DFMO Maintenance for Patients With Relapsed/Refractory Ewing Sarcoma or Osteosarcoma (clinicaltrials.gov) - P1/2 | N=15 | Recruiting | Sponsor: Montefiore Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open • Ewing Sarcoma • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

Norgine welcomes TGA registration in Australia of IFINWIL (eflornithine) for adults and children diagnosed with high-risk neuroblastoma (HRNB) (PRNewswire) - "Norgine is pleased to announce that the Australian Therapeutic Goods Administration (TGA) has approved the registration of IFINWIL (eflornithine) for the treatment of adults and paediatric patients with high-risk neuroblastoma (HRNB), who have responded to prior multiagent, multimodality therapy....'This approval, as part of the Project Orbis initiative, represents a vital step forward in ensuring access to innovative cancer treatments for patients around the world,'..."

Approval • Neuroblastoma

DFMO Maintenance for Patients With Relapsed/Refractory Ewing Sarcoma or Osteosarcoma (clinicaltrials.gov) - P1/2 | N=15 | Not yet recruiting | Sponsor: Montefiore Medical Center

New P1/2 trial • Ewing Sarcoma • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

Norgine submits Marketing Authorisation Application to the European Medicines Agency for eflornithine (difluoromethylornithine [DFMO]) in high-risk neuroblastoma (PRNewswire) - "Norgine today announced that it completed its marketing authorisation application filing to European Medicines Agency (EMA) for eflornithine in high-risk neuroblastoma (HRNB). This follows the submissions in April 2024, via Project Orbis, in Australia, Switzerland and the United Kingdom. This milestone further supports Norgine's efforts to give patients access to eflornithine and bring a further treatment option in the field of paediatric oncology."

EMA filing • Project Orbis • Neuroblastoma

Australian Neuroblastoma Patients Access Iwilfin Free-of-charge (NAVLIN DAILY) - "For the first time, high-risk neuroblastoma patients have access to Iwilfin (difluoromethylornithine), thanks to funding from the Australian government. The scheme, meant for children and young adults, was made possible through an agreement with Dutch drugmaker Norgine. In parallel, Norgine is pursuing approvals for listing on Australia’s Pharmaceutical Benefits Scheme (PBS) and the establishment of a compassionate access scheme."

Reimbursement • Neuroblastoma

Norgine B.V. submits Marketing Authorisation Application via Project Orbis for eflornithine (difluoromethylornithine [DFMO]) in high-risk neuroblastoma (PRNewswire) - "Norgine B.V. today announced its first marketing authorisation application submissions on 10 April 2024, seeking approval for eflornithine in high-risk neuroblastoma (HRNB), via Project Orbis in Australia, Switzerland and the United Kingdom. This milestone supports Norgine's efforts to deliver patient access to eflornithine and bring a further treatment option in the field of paediatric oncology."

European regulatory • Non-US regulatory • Project Orbis • Neuroblastoma • Oncology • Solid Tumor

FDA approves eflornithine for adult and pediatric patients with high-risk neuroblastoma (Targeted Oncology) - "...the Food and Drug Administration approved eflornithine (IWILFIN, USWM, LLC) to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy...Efficacy was evaluated in an externally controlled trial comparing outcomes from Study 3b (investigational arm) and Study ANBL0032 (clinical trial-derived external control arm)...This review used the Real-Time Oncology Review (RTOR) pilot program..."

NDA • Neuroblastoma