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Sotorasib (NSCLC) ' Addendum to Commission A23-06 1 Translation of addendum A23-53 Sotorasib (NSCLC) – Addendum zum Projekt A23-06 (Dossierbewertung). Please note: This document was translated by an external translator and is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Sotorasib (NSCLC ) Addendum to Project A23-06 (dossier assessment)1 ADDENDUM Project: A23-53 Version: 1.0 Status: 7 July 2023 Addendum A23-53 Version 1.0 Sotorasib – Addendum to Project A23-06 7 July 2023 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Sotorasib (NSCLC) – Addendum to Project A23-06 Commissioning agency
Sotorasib (NSCLC) ' Benefit assessment according to '35a Social Code Book V 1 Translation of Sections I 1 to I 6 of the dossier assessment Sotorasib (NSCLC) – Nutzenbewertung gemäß § 35a SGB V (Ablauf Befristung). Please note: This document was translated by an external translator and is provided as a service by IQWiG to English-la nguage readers. However, solely the German original text is absolutely authoritative and legally binding. Sotorasib (NSCLC) Benefit assessment according to §35a SGB V1 (assessment after expiry of the decision) EXTRACT Project: A23-06 Version: 1.0 Status: 25 April 2023 Extract of dossier assessment A23-06 Version 1.0 Sotorasib ( NSCLC) 25 April 2023 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality
Sotorasib (Lumakras) - non'small cell lung cancer View of Sotorasib (Lumakras) | Canadian Journal of Health TechnologiesReturn to Article DetailsSotorasib (Lumakras)
Sotorasib (NSCLC) - Benefit assessment according to '35a Social Code Book V 1 Translation of Sections 2.1 to 2.5 of the dossier assessment Sotorasib (NSCLC) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 12 May 2022). Please note: This document was translated by an external translator and 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. A22-28 Sotorasib (NSCLC) – Benefit assessment according to §35a Social Code Book V1 Extract of dossier assessment A22-28 Version 1.0 Sotorasib (NSCLC) 12 May 2022 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details
WITHDRAWN - KRAS G12C variant testing to determine eligibility for PBS-subsidised sotorasib second-line therapy in patients with locally advanced or metastatic non small cell lung cancer Public Summary Document Application No. 1669 – KRAS G12C variant testing to determine eligibility for PBS-subsidised sotorasib second-line therapy in patients with locally advanced or metastatic non small cell to determine eligibility for treatment with sotorasib in patients diagnosed with advanced (stage IIIB/IV) non-squamous or not otherwise specified (NOS) non-small cell lung cancer (NSCLC) • Pharmaceutical Benefits Scheme (PBS) Section 85 Authority Required listing of sotorasib for the treatment of advanced (stage IIIB/IV) non-squamous or NOS NSCLC in patients who have evidence of the KRAS G12C variant. 2
Sotorasib (Lumakras) - To treat adults with non-small cell lung cancer Drug Approval Package: Lumakras * 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
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Sotorasib (Lumakras) - treatment of adult patients with Kirsten rat sarcoma viral oncogene homolog (KRAS)-G12C-mutated locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) Search Page - Drug and Health Product Register * Skip to main content * Skip to "About this site"Language selection * FrançaisGovernment of CanadaSearch and menus * Search
Sotorasib (Lumykras) - non-small cell lung cancer (NSCLC) PROSPEROInternational prospective register of systematic reviews Print | PDFEffectiveness of Occupational Therapy for improving negative and cognitive symptoms among schizophreniaPavunkumar R, S.G.PraveenTo enable PROSPERO to focus on COVID-19 submissions, this registration record has undergone basic automated checks for eligibility
Sotorasib (Lumykras) as monotherapy for the treatment of advanced NSCLC with KRAS G12C mutation. Sotorasib (Lumykras®): Sotorasib (Lumykras®) as monotherapy for the treatment of advanced NSCLC with KRAS G12C mutation. Update May 2022 - Repository of AIHTA GmbH English | Deutsch Atom RSS 1.0 RSS 2.0 * Simple search * Advanced search * Help * Services * Login * Browse * Type * Subject * Author / Editor * Institution * YearAIHTA - Publications - Search - Sotorasib (Lumykras®): Sotorasib (Lumykras®) as monotherapy for the treatment of advanced NSCLC with KRAS G12C mutation. Update May 2022 Rothschedl, E. and Wolf, S.(2021):Sotorasib (Lumykras®): Sotorasib (Lumykras®) as monotherapy for the treatment of advanced NSCLC with KRAS G12C mutation. Update May 2022. Oncology Fact Sheet Nr. 71.Preview
Management of sotorasib-related adverse events and hepatotoxicities following anti-PD-(L)1 therapy: Experience with sotorasib in two French anti-cancer centers and practical guidance proposal. Sotorasib is a first-in-class KRASG12C inhibitor that showed significant clinical activity in KRAS-mutated non-small cell lung cancer (NSCLC). The most frequent grade 3 or 4 sotorasib-related adverse events (AEs) were diarrhea (4-12 %) and hepatotoxicity (10.1-15.1 %). Data is lacking about the management of these AEs, especially in patients receiving sequential anti-PD-(L)1 and sotorasib therapy. Our aim was to report the management of grade ≥ 2 sotorasib-related AEs in real-world setting and to propose practical guidance for the management of grade ≥ 2 sotorasib-related AEs and more generally
Sotorasib for Vascular Malformations Associated with KRAS G12C Mutation. gain-of-function mutations are frequently observed in sporadic arteriovenous malformations. The mechanisms underlying the progression of such -driven malformations are still incompletely understood, and no treatments for the condition are approved. Here, we show the effectiveness of sotorasib, a specific KRAS G12C inhibitor , in reducing the volume of vascular malformations and improving survival in two mouse models carrying a mosaic G12C mutation. We then administered sotorasib to two adult patients with severe G12C-related arteriovenous malformations. Both patients had rapid reductions in symptoms and arteriovenous malformation size. Targeting KRAS G12C appears to be a promising therapeutic approach for patients with G12C
Severe sotorasib-related hepatotoxicity and non-liver adverse events associated with sequential anti-PD(L)1 and sotorasib therapy in KRAS(G12C)-mutant lung cancer. Sequential anti-PD-(L)1 followed by small targeted therapy use is associated with increased prevalence of adverse events (AEs) in non-small cell lung cancer (NSCLC). KRASG12C inhibitor sotorasib may trigger severe immune-mediated hepatotoxicity when used in sequence or in combination with anti-PD-(L)1. This study was designed to address whether sequential anti-PD-(L)1 and sotorasib therapy increases the risk of hepatotoxicity and other AEs. This is a multicenter, retrospective study of consecutive advanced KRAS-mutant NSCLC treated with sotorasib outside clinical trials in 16 French medical centers. Patient records were reviewed
Sotorasib's Accelerated Approval: Wrong Dose and Indication. This Viewpoint reviews the accelerated approval process and lack of postapproval studies to verify its benefit as it applied to sotorasib, a treatment for non–small cell lung cancer with the KRASg12c mutation, and recommends measures to ensure confirmatory follow-up studies.
Impact of Acid-Reducing Agents on Sotorasib Pharmacokinetics and Potential Mitigation of the Impact by Coadministration With an Acidic Beverage. Sotorasib exhibits pH-dependent solubility, making it susceptible to altered exposures when coadministered with acid-reducing agents (ARAs). Several clinical studies were conducted to investigate the impact of ARAs on sotorasib pharmacokinetics under different clinically relevant scenarios and to identify potential mitigation strategies. Upon coadministration of 960 mg of sotorasib and 40 mg of omeprazole under fasted conditions, sotorasib area under the concentration-time curve (AUC) and maximum observed plasma concentration (C) decreased approximately 42% and 57%, respectively. Following coadministration with 40 mg of famotidine under fed conditions
A single-arm, phase II study of sotorasib plus carboplatin/pemetrexed in advanced non-squamous non-small cell lung cancer patients with KRAS G12C mutation (WJOG14821L, SCARLET). The efficacy and safety of sotorasib plus platinum-doublet chemotherapy in KRAS G12C-mutated non-squamous non-small cell lung cancer (non-Sq NSCLC) were previously reported with limited follow-up period. SCARLET was a single-arm phase II study of chemotherapy-naïve patients with KRAS G12C-mutated non-Sq NSCLC. Participants received sotorasib 960 mg daily plus four cycles of carboplatin (area under the curve, 5)/pemetrexed 500 mg/m, followed by sotorasib/pemetrexed until disease progression. The primary endpoint was the overall response rate (ORR); secondary endpoints were progression-free survival (PFS), overall