№ files_lp_4_process_3_122010
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Regulatory and reimbursement submission excerpt outlining proposed Pharmaceutical Benefits Scheme authority-required restrictions, clinical criteria, dosing regimen, and comparator treatments for pralatrexate in adult patients with relapsed or refractory peripheral T-cell lymphoma.
Year: 2017
Country: Australia
Program: Pharmaceutical Benefits Scheme (PBS)
Section: Section 100 Highly Specialised Drugs Program
Regulatory Authority: Pharmaceutical Benefits Advisory Committee (PBAC)
Regulatory Agency: Department of Human Services
Drug Name: Pralatrexate
Brand Name: Folotyn®
Manufacturer: Mundipharma Pty Ltd
Dosage Form: Solution for intravenous infusion, 20 mg in 1 mL
Maximum Quantity: 80 mg
Indication: Relapsed or chemotherapy-refractory peripheral T-cell lymphoma
Target Population: Adult patients with relapsed or refractory peripheral T-cell lymphoma after first-line chemotherapy
Treatment Regimen: 30 mg/m² intravenous infusion weekly for six weeks followed by one week rest
Treatment Phases: Initial treatment; continuing treatment
Restriction Type: Authority Required (Private and Public Hospital)
Clinical Criteria: Relapsed or chemotherapy-refractory disease following front-line curative intent chemotherapy
Comparator Treatments: DHAP, brentuximab, gemcitabine-containing regimens, methotrexate, romidepsin, ESHAP, ICE
Outcome Measures: Overall survival, overall response rate, safety
Regulatory Status: Registered by the Therapeutic Goods Administration (TGA) in December 2014
Therapeutic Area: Oncology / Hematologic malignancies
Price: 8 / 10 USD
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NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCESINGLE TECHNOLOGY APPRAISALAPPEAL HEARINGAdvice on isatuximab with pomalidomide and dexamethasone for treating relapsed and refractory multiple myeloma [ID4067]: Decision of the panel.
Year: 2024
Region / city: United Kingdom
Topic: Health technology assessment
Document type: Appeal hearing report
Organization: National Institute for Health and Care Excellence (NICE)
Author: NICE
Target audience: Healthcare professionals, industry representatives, public
Period of validity: Not specified
Approval date: 23 September 2024
Date of changes: Not specified
IXAZOMIB in combination with lenalidomide and dexamethasone for the treatment of relapsed and/or refractory multiple myeloma
Year: 2016
Region / city: Australia
Topic: Multiple myeloma treatment
Document type: Submission for listing consideration
Organ / institution: PBAC (Pharmaceutical Benefits Advisory Committee)
Author: Takeda Pharmaceuticals Australia Pty Ltd
Target audience: PBAC, healthcare professionals
Period of validity: Ongoing treatment
Approval date: 15 November 2016
Date of changes: N/A
High-Dose Methotrexate-Induced Seizures in a Relapsed B-ALL Patient and Management Outcomes
Year: 2026
Region / City: Not specified
Topic: Pediatric Hematology, Neurotoxicity
Document Type: Case Report
Institution: Not specified
Author: Not specified
Target Audience: Medical professionals
Patient Age: 6–14 years
Diagnosis: Relapsed B-cell Acute Lymphoblastic Leukemia (B-ALL)
Treatment Protocols: MRC-11, BFM 2002
Drug: High-Dose Methotrexate (HDMTX), Intrathecal Methotrexate (ITMTX), Levetiracetam, Diazepam
Clinical Events: Generalised tonic-clonic seizures, neurotoxicity
Outcome: Successful continuation of HDMTX and ITMTX without further seizures
Follow-up Duration: 2 years 3 months of anti-convulsant therapy
Imaging Findings: Normal brain MRI, hepatosplenomegaly on abdominal ultrasound
Laboratory Findings: Bone marrow immunophenotyping and cytogenetics detailed in report
Risk Stratification: Intermediate
Carflizomib With and Without Ibrutinib in Frontline and Relapsed / Refractory WM (CZAR01)
Year: 2024
Region / City: Europe
Topic: Waldenstrom’s Macroglobulinemia, Treatment Approaches
Document Type: Clinical Trial Report
Author: Meletios Dimopoulos, Maria Gavriatopoulou, Efstathios Kastritis, Christian Buske
Target Audience: Medical Researchers, Oncologists, Hematologists
Study Phase: Phase II
Date of Approval: June 2024
Date of Changes: N/A
Primary Endpoint: Achievement of CR / VGPR at 12 and 24 months
Secondary Endpoints: Time to best response, time to first response, time to treatment failure, remission duration, progression free survival, cause specific survival, overall survival, safety, quality of life
National Institute for Health and Care Excellence Single Technology Appraisal (STA) Gilteritinib for treating relapsed or refractory acute myeloid leukaemia (ID1484) Response to consultee and commentator comments on the draft remit and draft scope (pre-referral) (revised June 2019)
Year: 2019
Region / City: United Kingdom
Topic: Cancer, Hematology
Document Type: Response to Consultation
Organization: National Institute for Health and Care Excellence (NICE)
Author: National Institute for Health and Care Excellence (NICE)
Target Audience: Healthcare professionals, policy makers
Effective Period: Not specified
Approval Date: Not specified
Amendment Date: June 2019
Topics: Pralatrexate Folotyn relapsed