№ lp_2_3_31322
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Regulatory submission outlining the proposed PBS listing, clinical criteria, prescribing conditions, and cost-effectiveness basis for eflornithine in post-maintenance treatment of high-risk neuroblastoma.
Document Type: Category 1 submission for Authority Required (Written) listing
Medicine: Eflornithine (Ifinwil®) 250 mg tablet
Active Ingredient: Eflornithine (as hydrochloride)
Sponsor: Norgine Pty Ltd
Regulatory Authority: Therapeutic Goods Administration (TGA)
Advisory Body: Pharmaceutical Benefits Advisory Committee (PBAC)
Program: Section 100 – Highly Specialised Drugs Program
Schedule: General Schedule (Code GE – Schedule 85)
Indication: High-risk neuroblastoma in patients aged 1 year and older in remission after prior therapy
Population: Patients ≥1 year with high-risk neuroblastoma meeting INRG, COG, or SIOPEN criteria
Treatment Phase: Initial and Continuing Treatment
Comparator: Standard of care (follow-up and monitoring)
Clinical Outcomes: Event-free survival, overall survival, safety
Dosage Form: 250 mg oral tablet
Treatment Duration: Up to 27 cycles (2 years) or until disease progression
Orphan Drug Designation: Granted 7 December 2022
Submission Pathway: TGA/PBAC Parallel Process
Restriction Type: Authority Required (Full assessment – written)
Prescriber Type: Medical Practitioners (paediatric oncologist or haematologist for initiation)
Price: 8 / 10 USD
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Development of imaging features to refine risk stratification in high-risk neuroblastoma
Note: Year
Contextual description: A research paper providing advanced imaging analysis methods for refining risk assessment in high-risk neuroblastoma patients.
A Novel Standard for Systematic Reporting of Neuroblastoma Surgery: The International Neuroblastoma Surgical Report Form (INSRF)
Type: Original Report
Initiative: Joint initiative by SIOPEN, COG and GPOH
Subject: Standardized reporting of neuroblastoma surgery
Authors: Lucas E. Matthyssens et al.
Affiliated Organizations: SIOP Europe International Neuroblastoma Study Group (SIOPEN); Children’s Oncology Group (COG); Gesellschaft fuer Paediatrische Onkologie und Haematologie (GPOH)
Institutions: Multiple pediatric surgical and oncology centers in Belgium, USA, The Netherlands, United Kingdom, Norway, France, Sweden, Italy, Spain and Germany
Corresponding Author: Dr Lucas E. Matthyssens
Presentation: 50th Congress of the International Society of Pediatric Oncology (SIOP) and the International Society for Pediatric Surgical Oncology (IPSO), November 16, 2018, Kyoto, Japan
Conflicts of Interest: None declared
Funding: No funding received
Keywords: Neuroblastoma; surgery; biopsy; resection; tumor; standardization; reporting; postoperative complication; outcome; Clavien-Dindo Classification
Scope: International consensus on structured documentation of neuroblastoma-related surgical procedures and outcomes
Target Field: Pediatric surgical oncology
Topics: Eflornithine Ifinwil neuroblastoma