预约演示

Norgine Norgine seeks approval for high-risk neuroblastoma treatment

2024-04-16

交易

引进/卖出上市批准临床结果临床3期

Eflornithine received approval from the US FDA as the first oral maintenance therapy for high-risk neuroblastoma. Credit: Kateryna Kon / Shutterstock.com.

Eflornithinesought approval for eflornitUS FDAdifluoromethylornithine [DFMO]) for the trehigh-risk neuroblastoma high-risk neuroblastoma (HRNB).

Norgineelopment marks the first eflornithinethdifluoromethylornithine [DFMO]ed in Australia, Switzerland and the high-risk neuroblastoma (HRNB)ug.

The move is part of the Project Orbis initiative, aiming to expedite patient access to new treatment options.

Norgine has an exclusive licensing partnership with speciality pharmaceutical company US WorldMeds, under which Norgine will execute the registration and commercialisation activities of eflornithine in Europe, Australia and New Zealand.

Norginethine received approval from the US Food and Drug Administration (FDA) as the firsWorldMedsintenance therNorgine HRNB on 13 December 2023.eflornithine

Eflornithine Food and Drug Administration (FDA)

B-Vaxx by Imugene for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer): Likelihood of Approval

B-Vaxx by Adaptimmune Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer Human Epidermal Growth Factor Receptor 2mia (ALL, Acute LymphoblaHER2 + Breast Cancerelihood of Approval

It is indicated to reduce the relapse risk in adult and paediatric patients who have previously received therapies.

TC-110A’s Adaptimmune Therapeutics compAcute Lymphocytic LeukemianvestigAcute Lymphoblastic Leukemiaa clinical-trial-derived external control arm of Study ANBL0032.

The findings demonstrated that eflornithine treatment improved event-free survival and overall survival rates in patients with HRNB. These outcomes were notably better than those observed in patients treated with the standard of care without eflornithine.

Norgine chief medical officer Dr David Gillen stated: “These submissions via Project Orbis represent an important first step in the regulatory process for eflornithine and re-emphasise Norgine’s passion and commitment in attempting to secure additional treatment options for patients living with HRNB, a condition with a high level of unmet medical need.”

LastFDAnth, Norgine and Fennec Pharmaceuticals signed an exclusive licence agreement for the marketing of hearing loss therapy Pedmarqsi for paediatric cancer patients undergoing chemotherapy.

更多内容，请访问原始网站

文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。

机构