MedPath

Norgine Seeks Approval for Eflornithine in High-Risk Neuroblastoma via Project Orbis

• Norgine B.V. has submitted marketing authorization applications for eflornithine in Australia, Switzerland, and the United Kingdom for high-risk neuroblastoma (HRNB). • The submissions are part of Project Orbis, an initiative to expedite the approval of innovative oncology products across multiple countries. • Eflornithine is intended as an oral maintenance therapy to reduce the risk of relapse in pediatric and adult patients with HRNB. • FDA approved eflornithine in December 2023 based on trials showing improved event-free and overall survival compared to standard of care.

Norgine B.V. has announced the submission of marketing authorization applications for eflornithine (difluoromethylornithine, DFMO) in high-risk neuroblastoma (HRNB) to regulatory agencies in Australia, Switzerland, and the United Kingdom. The submissions, made on April 10, 2024, are being pursued via Project Orbis, an initiative designed to accelerate the global availability of innovative cancer therapies.
The application seeks to introduce eflornithine as a maintenance therapy for HRNB patients who have already undergone standard treatments. This regulatory step follows the U.S. Food and Drug Administration (FDA) approval of eflornithine on December 13, 2023, for the same indication.

Clinical Data Supporting Eflornithine

The FDA's approval of eflornithine was based on data from a clinical trial comparing outcomes from Study 3b (NCT02395666) and Study ANBL0032 (NCT00026312). The results indicated that eflornithine significantly improved event-free survival and overall survival compared to patients treated with standard of care alone.

The Need for New HRNB Therapies

HRNB remains a challenging disease, with approximately 30% of patients relapsing after initial treatment. Relapsed HRNB carries a poor prognosis, with long-term survival rates estimated as low as 15%. Currently, outside of the United States, there are limited approved options for sustaining remission in HRNB patients following standard of care.

Norgine's Commitment

Dr. David Gillen, Chief Medical Officer at Norgine, stated that these submissions via Project Orbis are a crucial step in securing additional treatment options for HRNB patients, highlighting the company's commitment to addressing this unmet medical need.

About Project Orbis

Project Orbis, an initiative of the US FDA Oncology Center of Excellence (OCE), facilitates concurrent submission and collaborative review of oncology products among international regulatory authorities. Partners include the United Kingdom Medicines and Healthcare Products regulatory Agency (UK MHRA), Australia Therapeutic Goods Administration (TGA), Canada (Health Canada), Singapore (Health Sciences Authority (HSA), Switzerland (Swissmedic), Brazil (Agência Nacional de Vigilância Sanitária (ANVISA), Israel (Ministry of Health).
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

Norgine Seeks EMA Approval for Eflornithine in High-Risk Neuroblastoma

Norgine has submitted a marketing authorization application to the EMA for eflornithine to treat high-risk neuroblastoma (HRNB).
The application follows prior submissions in Australia, Switzerland, and the United Kingdom under Project Orbis.

Pharmaessentia Corp. Advances with Phase III Clinical Trial for P1101 Targeting Pre-fibrotic/Early PMF

PharmaEssentia Corp. has submitted a Phase III clinical trial protocol for Ropeginterferon alfa-2b (P1101) to the China National Medical Products Administration, targeting adult patients with pre-fibrotic/early primary myelofibrosis or overt primary myelofibrosis at low or intermediate-1 risk.

Eflornithine (Iwilfin) Approved for High-Risk Neuroblastoma to Reduce Relapse Risk

Eflornithine (Iwilfin) is now FDA-approved to reduce the risk of relapse in high-risk neuroblastoma patients who have shown partial response to prior therapies.
The approval was based on a Phase II trial demonstrating significantly improved event-free survival and overall survival compared to historical controls.

EU Approves AbbVie's Elahere for Platinum-Resistant Ovarian Cancer

The European Commission has granted marketing authorization to AbbVie's Elahere (mirvetuximab soravtansine) for platinum-resistant ovarian cancer treatment.
Elahere is the first folate receptor alpha (FRα)-directed antibody-drug conjugate approved in the EU, targeting FRα-positive ovarian cancer in adults.

Nerandomilast Meets Primary Endpoint in Phase III FIBRONEER-IPF Trial

Boehringer Ingelheim's nerandomilast met the primary endpoint in the Phase III FIBRONEER-IPF trial, showing a significant absolute change from baseline in Forced Vital Capacity (FVC) at week 52 compared to placebo.
The FIBRONEER-IPF trial, the largest IPF trial to date, recruited patients from over 330 sites across more than 30 countries, demonstrating broad global participation.

Nerandomilast Meets Primary Endpoint in Phase III FIBRONEER-IPF Trial

Boehringer Ingelheim's nerandomilast met the primary endpoint in the Phase III FIBRONEER-IPF trial, showing a significant change in Forced Vital Capacity (FVC) at week 52 compared to placebo.
The FIBRONEER-IPF trial, the largest IPF trial to date, recruited patients from over 330 sites across more than 30 countries, demonstrating broad global participation.

Mirdametinib's NDA for NF1-PN Granted Priority Review by FDA

The FDA has granted priority review to SpringWorks Therapeutics' NDA for mirdametinib in treating Neurofibromatosis Type 1-associated plexiform neurofibromas (NF1-PN).
The PDUFA target action date is set for February 28, 2025, with the FDA indicating no current plans for an advisory committee meeting.

Eflornithine Approved for High-Risk Neuroblastoma: EMA Approval Still Pending

Eflornithine (Iwilfin) is FDA-approved for high-risk neuroblastoma in adults and children who have shown a partial response to prior therapies, including anti-GD2 immunotherapy.
Clinical trials demonstrated that eflornithine reduces the risk of relapse, with a hazard ratio for event-free survival of 0.48 and a hazard ratio for overall survival of 0.32.

Eflornithine Approved by FDA for High-Risk Neuroblastoma to Reduce Relapse Risk

The FDA has approved eflornithine (Iwilfin) to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB).
The approval is for patients who have achieved at least a partial response to prior multi-agent, multimodality therapy, including anti-GD2 immunotherapy.

FDA Approves Eflornithine for High-Risk Neuroblastoma to Reduce Relapse Risk

The FDA has approved eflornithine (Iwilfin) to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB).
The approval is for patients who have demonstrated at least a partial response to prior multiagent, multimodality therapy, including anti-GD2 immunotherapy.

Reference News

[1]
Norgine B.V. submits Marketing Authorisation Application via Project ...
presseportal.de · Apr 15, 2024

Norgine B.V. submitted a Marketing Authorisation Application for eflornithine in high-risk neuroblastoma via Project Orb...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy