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Larotrectinib (Vitrakvi) and cancers with an NTRK gene fusion. Grossly inadequate evaluation as of early 2021 Prescrire IN ENGLISH - Spotlight ''Larotrectinib (Vitrakvi°) and cancers with an NTRK gene fusion. Grossly inadequate evaluation as of early 2021'', 1 April 2021 {1}##LOC[OK]## {1} ##LOC[OK]## ##LOC[Cancel]## {1}##LOC[OK]####LOC[Cancel]## Register online| Log in| My Prescrire Issue * Prescrire events * A global network Offers * Subscribe now * Solidarity Subscription Rate * Subscribers: register online * Prescrire's other products * Free Special Edition * Sign up to receive the newsletter english.prescrire.org > Spotlight > 100 most recent > Larotrectinib (Vitrakvi°) and cancers with an NTRK gene fusion. Grossly inadequate evaluation as of early 2021 SpotlightEvery month
Testing for neurotrophic tyrosine receptor kinase (NTRK) gene fusion status, in patients with locally advanced or metastatic solid tumours, to determine eligibility for Larotrectinib 1 Application 1602.1 – NTRK fusion testing in patients with locally advanced or metastatic solid tumour to determine eligibility for larotrectinib (Vitrakvi) Applicant: Bayer Australia Ltd Date of MSAC ), fluorescence in situ hybridisation (FISH) and next generation sequencing (NGS) testing. These were for the evaluation of a neurotrophic tyrosine receptor kinase (NTRK) gene fusion to determine eligibility for treatment with larotrectinib in paediatric patients with locally advanced or metastatic solid tumours of any origin and in adult patients with locally advanced or metastatic mammary analogue secretory
Larotrectinib (solid tumours) - Benefit assessment according to §35a Social Code Book V 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Larotrectinib (solide Tumore mit einer neurotrophen Tyrosin-Rezeptor-Kinase [NTRK]-Genfusion) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 January 2020). Please note : This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Extract IQWiG Reports – Commission No. A19-90 Larotrectinib (solid tumours with neurotrophic tyrosine receptor kinase [NTRK] gene fusion) – Benefit assessment according to §35a Social Code Book V1 Extract of dossier assessment A19-90 Version 1.0
Larotrectinib (solid tumours with neurotrophic tyrosine receptor kinase [NTRK] gene fusion) - Addendum to Commission A19-90 1 Translation of addendum A20-17 Larotrectinib (solide Tumore mit einer neurotrophen Tyrosin-Rezeptor-Kinase [NTRK]-Genfusion) – Addendum zum Auftrag A19-90 (Version 1.0; Status: 13 March 2020). Please note : This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Addendum 13 March 2020 1.0 Commission: A20-17 Version: Status: IQWiG Reports – Commission No. A20-17 Larotrectinib (solid tumours with neurotrophic tyrosine receptor kinase [NTRK] gene fusion) – Addendum to Commission A19-901 Addendum A20-17
Larotrectinib Terms of use - Canada.ca * Skip to main content * Skip to "About government" Language selection * FrançaisSearchSearch Canada.ca Search Topics menuMain Menu You are here: 1. Home 2. Health 3. Drug and health products 4. Licensing, authorizing and manufacturing drug and health products 5. Drug and health product review and approval 6. Clinical information on drugs and health
Testing for neurotrophic tyrosine receptor kinase (NTRK) gene fusion status, in patients with locally advanced or metastatic solid tumours, to determine eligibility for larotrectinib MSAC - 1602 - Testing for neurotrophic tyrosine receptor kinase (NTRK) gene fusion status, in patients with locally advanced or metastatic solid tumours, to determine eligibility for larotrectinib Skip to content * MSAC Consultation Process * MSAC Applications * Application Page * Utilisation Monitoring Process * You are here: * Medical Services Advisory Committee / * MSAC Applications / * Application Page /1602 - Testing for neurotrophic tyrosine receptor kinase (NTRK) gene fusion status, in patients with locally advanced or metastatic solid tumours, to determine eligibility for larotrectinib Page
Advice on a potential candidate for conditional inclusion of larotrectinib (Vitrakvi) for solid tumours with NTRK gene fusion Advice on a potential candidate for conditional inclusion of larotrectinib (Vitrakvi®) for solid tumours with NTRK gene fusion | Letter | National Health Care Institute Go to content You are here: Home Publications Advice on a potential candidate for conditional inclusion of larotrectinib (Vitrakvi®) for solid tumours with NTRK gene fusion Search within English part of National Health Care Institute Search Advice on a potential candidate for conditional inclusion of larotrectinib (Vitrakvi®) for solid tumours with NTRK gene fusionZorginstituut Nederland recommends that larotrectinib should be designated as a potential candidate for conditional inclusion. Larotrectinib is licensed
Follow-up advice on conditional inclusion of larotrectinib (Vitrakvi) Follow-up advice on conditional inclusion of larotrectinib (Vitrakvi®) | Report | National Health Care Institute Go to content You are here: Home Publications Follow-up advice on conditional inclusion of larotrectinib (Vitrakvi®) Search within English part of National Health Care Institute Search Follow-up advice on conditional inclusion of larotrectinib (Vitrakvi®)Zorginstituut Nederland recommends the Minster for Medical Care that larotrectinib (Vitrakvi®) should be conditionally included in the basic health care package for treating adult and paediatric patients with solid tumours (cancer) that express a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. This is a follow-up advise to the previous recommendation
Testing for neurotrophic tyrosine receptor kinase (NTRK) gene fusion status, in patients with locally advanced or metastatic solid tumours, to determine eligibility for larotrectinib 1 Public Summary Document Application No. 1602 – Testing for neurotrophic tropomyosin receptor kinase (NTRK) gene fusion status, in patients with locally advanced or metastatic solid tumours, to determine eligibility for larotrectinib (Vitrakvi) – codependent Applicant: Bayer Australia Ltd Date of MSAC consideration: MSAC 80th Meeting, 26-27 November 2020 Context for decision: MSAC makes its advice in accordance with its Terms of Reference, visit the MSAC website 1. Purpose of application The integrated codependent submission (or applicant-developed assessment report (ADAR)) was received from Bayer Australia
Larotrectinib (Vitrakvi) - adult and pediatric patients with solid tumours Search Page - Drug and Health Product Register * Skip to main content * Skip to "About this site"Language selection * FrançaisGovernment of CanadaSearch and menus * Search and menusSearchSearch websiteSearchTopics menu * Jobs * Immigration * Travel * Business * Benefits * Health * Taxes * More servicesYou are here: 1
Efficacy and safety of larotrectinib in patients with TRK fusion gastrointestinal cancer. Larotrectinib is the first-in-class, highly selective TRK inhibitor with demonstrated efficacy in various TRK fusion solid tumours. We report the efficacy and safety of larotrectinib in patients with TRK fusion gastrointestinal (GI) cancer. Patients with TRK fusion GI cancer from NAVIGATE (NCT02576431) were ), and median overall survival was 13 months (95 % CI 7-29) and 29 months (95 % CI 7-NE), respectively. Grade 3/4 treatment-related adverse events (TRAEs) occurred in seven (16 %) patients. There were no deaths due to TRAEs. Larotrectinib demonstrated long durability, extended survival and manageable safety in patients with TRK fusion GI cancer, including those with MSI-H CRC. This supports the wider adoption
Elective Discontinuation of Larotrectinib in Pediatric Patients With TRK Fusion Sarcomas and Related Mesenchymal Tumors. Larotrectinib is a highly selective tropomyosin receptor kinase (TRK) inhibitor with efficacy in children with TRK fusion tumors. We evaluated patient outcomes after elective discontinuation of larotrectinib in the absence of disease progression in a protocol-defined wait -and-see subset analysis of eligible patients where treatment resumption with larotrectinib was allowed if disease progressed. We also assessed the safety and efficacy of larotrectinib in all pediatric patients with sarcoma. This cohort included 91 patients (younger than 18 years) from two clinical trials: infantile fibrosarcoma (49), other soft tissue sarcomas or related mesenchymal tumors (41
Long-Term Tumor Stability After First-Line Treatment With Larotrectinib in an Infant With NTRK2 Fusion-Positive High-Grade Glioma. Tissue-agnostic, molecularly targeted therapies are becoming increasingly common in cancer treatment. The molecular drivers of some classes and subclasses of tumors are rapidly being uncovered in an era of deep tumor sequencing occurring at the time of diagnosis. When are driven by receptor tyrosine kinase fusions, most commonly harboring an ALK, ROS1, NTRK, or MET fusion. Both larotrectinib and entrectinib are tropomyosin receptor kinase inhibitors with tissue-agnostic approvals for the treatment of patients with solid tumors harboring an NTRK fusion. This report discusses an 11-month-old female who presented with infantile spasms, found to have an unresectable, NTRK
A pilocytic astrocytoma with novel ATG16L1::NTRK2 fusion responsive to larotrectinib: a case report with genomic and functional analysis. The outcome of pilocytic astrocytoma (PA) depends heavily on the success of surgery. In cases where surgery alone is not curative, genetic analysis can be used to identify treatment targets for precision medicine. Here, we report a pediatric PA case -activated protein kinase pathway and the phosphoinositide 3-kinase oncogenic pathways through increased phosphorylation of extracellular signal-regulated kinase, AKT, and S6. As a result of the identification of the NTRK fusion, the patient was enrolled in a phase I/II clinical trial of the highly selective TRK inhibitor larotrectinib. The patient responded well without significant side effects, and 8
A phase II trial of larotrectinib in tumors with NTRK fusions or extremes of NTRK mRNA overexpression identified by comprehensive genomic profiling. TRK-inhibitors have demonstrated efficacy across several cancers with NTRK fusions. Their activity in cancers with NTRK overexpression remains unclear. This trial enrolled patients with advanced cancers harboring NTRK fusions or extreme mRNA system (CNS) and non-CNS tumours with NTRK fusions, the protocol was amended to permit NTRK overexpression. Seventeen patients were treated with larotrectinib: one glioblastoma with a SPECC1L::NTRK2 fusion (group 1), and a peripheral nerve sheath tumor with a TPM3::NTRK1 fusion and 15 patients with overexpression (group 2). The ORR was 6%. An additional 3 of 12 (25%) TTP1-evaluable patients achieved
Larotrectinib for Newly Diagnosed Infantile Fibrosarcoma and Other Pediatric NTRK Fusion-Positive Solid Tumors (Children's Oncology Group ADVL1823). The TRK inhibitor larotrectinib is US Food and Drug Administration approved for fusion-positive solid tumors that lack a satisfactory alternative or have progressed after treatment but has not been systematically studied as a frontline therapy with a defined duration of treatment. ADVL1823 evaluated larotrectinib in patients with newly diagnosed fusion-positive solid tumors with response-adapted duration of therapy and local control. Patients received larotrectinib twice daily in 28-day cycles for a predefined duration of treatment, ranging from 6 to 26 cycles depending on response to therapy and surgical resectability. The primary end point
Larotrectinib (Vitrakvi) - To treat patients whose cancers have a specific genetic feature (biomarker) Drug Approval Package: Vitrakvi (larotrectinib) * Skip to main page content * Skip to search * Skip to topics menu * Skip to common linksHHS U.S. Department of Health and Human Services U.S. Food and Drug Administration * Follow FDA * En EspañolSearch FDASubmit search * Popular Content * Home * Food * Drugs * Medical Devices * Radiation-Emitting Products * Vaccines, Blood & Biologics * Animal & Veterinary * Cosmetics * Tobacco Products * Home * Drugs * Drug Approvals and Databases * Drugs@FDADrug Approval Package: Vitrakvi (larotrectinib) * Share * Tweet * Linkedin * Pin it * More sharing options * Linkedin * Pin it * Email * Print Company: Place company name