James Patient Education Handouts (A – Z)
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Ripretinib Demonstrated Activity Across All KIT/PDGFRA Mutations In
Ripretinib demonstrated activity across all KIT/PDGFRA mutations in patients with fourth-line advanced gastrointestinal stromal tumor: Analysis from the phase 3 INVICTUS study Patrick Schöffski1, Sebastian Bauer2, Michael Heinrich3, Suzanne George4, John Zalcberg5, Hans Gelderblom6, Cesar Serrano Garcia7, Robin L Jones8, Steven Attia9, Gina D’Amato10, Ping Chi11, Peter Reichardt12, Julie Meade13, Kelvin Shi13, Ying Su13, Rodrigo Ruiz-Soto13, Margaret von Mehren14, Jean-Yves Blay15 1University Hospitals Leuven, Leuven, Belgium; 2West German Cancer Center, Essen, Germany; 3OHSU Knight Cancer Institute, Portland, OR, USA; 4Dana-Farber Cancer Institute, Boston, MA, USA; 5Monash University, Melbourne, VIC, Australia; 6Leiden University Medical Center, Leiden, Netherlands; 7Vall d’Hebron Institute of Oncology, Barcelona, Spain; 8Royal Marsden and Institute of Cancer Research, London, UK; 9Mayo Clinic, Jacksonville, FL, USA; 10Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL, USA; 11Memorial Sloan Kettering Cancer Center, New York, NY, USA; 12Sarcoma Center, Helios Klinikum Berlin-Buch, Berlin, Germany; 13Deciphera Pharmaceuticals, LLC, Waltham, MA, USA; 14Fox Chase Cancer Center, Philadelphia, PA, USA; 15Centre Leon Berard, Lyon, France KIT mutation analysis by combined tumor and liquid biopsy INTRODUCTION RESULTS Figure 7. Hazard ratio of PFS with different mutation groups by combined • Patients were grouped into 4 subsets: any KIT exon 9, any KIT exon 11, any KIT exon 13, and any KIT exon 17 tumor and liquid biopsy • Patients -
Master Agreement
MASTER AGREEMENT Between The Medical Society of Prince Edward Island And The Government of Prince Edward Island And Health PEI April 1, 2015 - March 31, 2019 MASTER AGREEMENT TABLE OF CONTENTS SECTION A - GENERAL Article A1. Purpose of Agreement .......................................................................................1 Article A2. Application, Duration and Amendments ..........................................................1 Article A3. Interpretation and Definitions ...........................................................................1 Article A4. Recognition .......................................................................................................3 Article A5. Administrative Authority ..................................................................................4 Article A6. Information .......................................................................................................4 Article A7. Correspondence.................................................................................................5 Article A8. Negotiations ......................................................................................................5 Article A9. General Grievance Procedure ...........................................................................6 Article A10. Mediation ..........................................................................................................7 Article A11. Interest Arbitration ............................................................................................8 -
Clinical Policy: Sorafenib (Nexavar)
Clinical Policy: Sorafenib (Nexavar) Reference Number: CP.PHAR.69 Effective Date: 07.01.11 Last Review Date: 05.21 Line of Business: Commercial, HIM, Medicaid Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description Sorafenib (Nexavar®) is a kinase inhibitor. FDA Approved Indication(s) Nexavar (sorafenib) is indicated for the treatment of: Unresectable hepatocellular carcinoma (HCC); Advanced renal cell carcinoma (RCC); Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria. It is the policy of health plans affiliated with Centene Corporation® that Nexavar is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Hepatocellular Carcinoma (must meet all): 1. Diagnosis of HCC; 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. Confirmation of Child-Pugh class A or B7 status; 5. Request meets one of the following (a or b):* a. Dose does not exceed 800 mg per day; b. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). *Prescribed regimen must be FDA-approved or recommended by NCCN Approval duration: Medicaid/HIM – 6 months Commercial – Length of Benefit B. Renal Cell Carcinoma (must meet all): 1. Diagnosis of advanced RCC; 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. Request meets one of the following (a or b):* Page 1 of 8 CLINICAL POLICY Sorafenib a. -
CDER Breakthrough Therapy Designation Approvals Data As of December 31, 2020 Total of 190 Approvals
CDER Breakthrough Therapy Designation Approvals Data as of December 31, 2020 Total of 190 Approvals Submission Application Type and Proprietary Approval Use Number Number Name Established Name Applicant Date Treatment of patients with previously BLA 125486 ORIGINAL-1 GAZYVA OBINUTUZUMAB GENENTECH INC 01-Nov-2013 untreated chronic lymphocytic leukemia in combination with chlorambucil Treatment of patients with mantle cell NDA 205552 ORIGINAL-1 IMBRUVICA IBRUTINIB PHARMACYCLICS LLC 13-Nov-2013 lymphoma (MCL) Treatment of chronic hepatitis C NDA 204671 ORIGINAL-1 SOVALDI SOFOSBUVIR GILEAD SCIENCES INC 06-Dec-2013 infection Treatment of cystic fibrosis patients age VERTEX PHARMACEUTICALS NDA 203188 SUPPLEMENT-4 KALYDECO IVACAFTOR 21-Feb-2014 6 years and older who have mutations INC in the CFTR gene Treatment of previously untreated NOVARTIS patients with chronic lymphocytic BLA 125326 SUPPLEMENT-60 ARZERRA OFATUMUMAB PHARMACEUTICALS 17-Apr-2014 leukemia (CLL) for whom fludarabine- CORPORATION based therapy is considered inappropriate Treatment of patients with anaplastic NOVARTIS lymphoma kinase (ALK)-positive NDA 205755 ORIGINAL-1 ZYKADIA CERITINIB 29-Apr-2014 PHARMACEUTICALS CORP metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib Treatment of relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients NDA 206545 ORIGINAL-1 ZYDELIG IDELALISIB GILEAD SCIENCES INC 23-Jul-2014 for whom rituximab alone would be considered appropriate therapy due to other co-morbidities -
2020 Master Class Course Best Practices and Expanding Treatment Options in Soft Tissue Sarcomas Including GIST George D
2020 Master Class Course Best Practices and Expanding Treatment Options in Soft Tissue Sarcomas including GIST George D. Demetri, MD FACP FASCO 1 George D. Demetri, MD Faculty Disclosure • Scientific consultant with sponsored research to Dana-Farber: Bayer, Pfizer, Novartis, Epizyme, Roche/Genentech, Epizyme, LOXO Oncology, AbbVie, GlaxoSmithKline, Janssen, PharmaMar, Daiichi-Sankyo, AdaptImmune • Scientific consultant: GlaxoSmithKline, EMD-Serono, Sanofi, ICON plc, MEDSCAPE, Mirati, WCG/Arsenal Capital, Polaris, MJ Hennessey/OncLive, C4 Therapeutics, Synlogic, McCann Health • Consultant/SAB member with minor equity holding: G1 Therapeutics, Caris Life Sciences, Erasca Pharmaceuticals, RELAY Therapeutics, Bessor Pharmaceuticals, Champions Biotechnology, Caprion/HistoGeneX • Board of Directors member and Scientific Advisory Board Consultant with minor equity holding: Blueprint Medicines, Translate BIO • Patents/Royalties: Novartis royalty to Dana-Farber for use patent of imatinib in GIST • Non-Financial Interests: AACR Science Policy and Government Affairs Committee Chair, Alexandria Real Estate Equities, Faculty of this CE activity may include discussions of products or devices that are not currently labeled for use by the FDA. The faculty have been informed of their responsibility to disclose to the audience if they will be discussing off label or investigational uses (any uses not approved by the FDA) of products or devices. 2 Soft Tissue Sarcomas: Approximate Anatomic Distribution Head and Neck 10% Upper extremities 15% Trunk 10% Retroperitoneal, pelvic and visceral Lower extremities 15% 50% (includes GIST and GYN sarcomas) Modified from Clark MA et al. NEJM 2005;353:701-11 3 Sarcomas represent an exceedingly diverse set of diseases Bone Sarcomas 10% GIST Un- differentiated Liposarcomas Leiomyo- Sarcomas 4 Ducimetiere et al. -
Rxoutlook® 1St Quarter 2019
® RxOutlook 1st Quarter 2020 optum.com/optumrx a RxOutlook 1st Quarter 2020 Orphan drugs continue to feature prominently in the drug development pipeline In 1983 the Orphan Drug Act was signed into law. Thirty seven years later, what was initially envisioned as a minor category of drugs has become a major part of the drug development pipeline. The Orphan Drug Act was passed by the United States Congress in 1983 in order to spur drug development for rare conditions with high unmet need. The legislation provided financial incentives to manufacturers if they could demonstrate that the target population for their drug consisted of fewer than 200,000 persons in the United States, or that there was no reasonable expectation that commercial sales would be sufficient to recoup the developmental costs associated with the drug. These “Orphan Drug” approvals have become increasingly common over the last two decades. In 2000, two of the 27 (7%) new drugs approved by the FDA had Orphan Designation, whereas in 2019, 20 of the 48 new drugs (42%) approved by the FDA had Orphan Designation. Since the passage of the Orphan Drug Act, 37 years ago, additional regulations and FDA designations have been implemented in an attempt to further expedite drug development for certain serious and life threatening conditions. Drugs with a Fast Track designation can use Phase 2 clinical trials to support FDA approval. Drugs with Breakthrough Therapy designation can use alternative clinical trial designs instead of the traditional randomized, double-blind, placebo-controlled trial. Additionally, drugs may be approved via the Accelerated Approval pathway using surrogate endpoints in clinical trials rather than clinical outcomes. -
Ripretinib Turns Off the Switch in GIST
RESEARCH HIGHLIGHTS TARGETED THERAPY Ripretinib turns off the switch in GIST More than 85% of cases of type II kinase inhibitors such as gastrointestinal stromal tumour imatinib, regorafenib and sunitinib. (GIST) harbour mutations in the To develop a novel KIT and genes encoding the receptor tyrosine PDGFRα inhibitor that is designed kinases KIT and platelet-derived to inhibit activating mutations in growth factor receptor α (PDGFRα). all relevant known exons, including Treatment of metastatic GIST has in the activation loop, Flynn and been transformed by kinase inhibitors colleagues used structure-based drug such as imatinib, which is considered design to create an inhibitor that to be one of the most successful could bind to key amino acid residues targeted agents ever developed. within the KIT switching mechanism. Plus Images Bank/Getty Image Rosario/The M. Antonio Credit: However, this type of inhibitor In vitro, ripretinib and other only blocks a limited number analogues both prevented KIT from conducted a first-in-human study to of KIT mutants, and secondary adopting a type I active conformation evaluate the safety and tolerability resistance mutations eventually and locked it in the inactive of ripretinib (NCT02571036). emerge. Now, Daniel Flynn, from conformation. The authors showed Patients with drug-resistant GIST Deciphera Pharmaceuticals, that ripretinib inhibited mutations harbouring a broad spectrum of and collaborators have designed across all six exons known to be KIT mutations were enrolled during ripretinib, an investigational mutated in KIT-driven GIST as well the dose-escalation phase of study. tyrosine kinase inhibitor that targets as mutations in PDGFRα in a panel At first assessment, two representative a broad spectrum of KIT and of GIST cell lines and cells expressing patients in this phase I study showed PDGFRα mutants. -
Standard Oncology Criteria C16154-A
Prior Authorization Criteria Standard Oncology Criteria Policy Number: C16154-A CRITERIA EFFECTIVE DATES: ORIGINAL EFFECTIVE DATE LAST REVIEWED DATE NEXT REVIEW DATE DUE BEFORE 03/2016 12/2/2020 1/26/2022 HCPCS CODING TYPE OF CRITERIA LAST P&T APPROVAL/VERSION N/A RxPA Q1 2021 20210127C16154-A PRODUCTS AFFECTED: See dosage forms DRUG CLASS: Antineoplastic ROUTE OF ADMINISTRATION: Variable per drug PLACE OF SERVICE: Retail Pharmacy, Specialty Pharmacy, Buy and Bill- please refer to specialty pharmacy list by drug AVAILABLE DOSAGE FORMS: Abraxane (paclitaxel protein-bound) Cabometyx (cabozantinib) Erwinaze (asparaginase) Actimmune (interferon gamma-1b) Calquence (acalbrutinib) Erwinia (chrysantemi) Adriamycin (doxorubicin) Campath (alemtuzumab) Ethyol (amifostine) Adrucil (fluorouracil) Camptosar (irinotecan) Etopophos (etoposide phosphate) Afinitor (everolimus) Caprelsa (vandetanib) Evomela (melphalan) Alecensa (alectinib) Casodex (bicalutamide) Fareston (toremifene) Alimta (pemetrexed disodium) Cerubidine (danorubicin) Farydak (panbinostat) Aliqopa (copanlisib) Clolar (clofarabine) Faslodex (fulvestrant) Alkeran (melphalan) Cometriq (cabozantinib) Femara (letrozole) Alunbrig (brigatinib) Copiktra (duvelisib) Firmagon (degarelix) Arimidex (anastrozole) Cosmegen (dactinomycin) Floxuridine Aromasin (exemestane) Cotellic (cobimetinib) Fludara (fludarbine) Arranon (nelarabine) Cyramza (ramucirumab) Folotyn (pralatrexate) Arzerra (ofatumumab) Cytosar-U (cytarabine) Fusilev (levoleucovorin) Asparlas (calaspargase pegol-mknl Cytoxan (cyclophosphamide) -
S.P. Strijk Stellingen
INIS-mf —11067 y i; ••Ht g S.P. STRIJK STELLINGEN 1. Het verschil in diagnostische nauwkeurigheid tussen CT en lymfografie bij patiënten met maligne lymfoom berust voornamelijk op een verschil in sensitiviteit ten nadele van CT. 2. CT is geen alternatief voor stadiëringslaparotomie. 3. De informatie verkregen met behulp van CT en lymfo- grafie is voor 85% overlappend en voor 15% aanvullend. Tegenstrijdige informatie kan meestal afdoende ver- klaard worden. 4. Het routinematig verrichten van een CT van de thorax als onderdeel van het stadiëringsonderzoek bij patiën- ten met de ziekte van Hodgkin of non-Hodgkin lymfoom is niet zinvol. 5. De in-vivo bepaling van de miltgrootte met behulp van de CT-miltindexberekening kan aanwijzingen geven over eventuele lymfoomlocalisatie in de milt bij .patiënten met de ziekte van Hodgkin of non-Hodgkin lymfoom. 6. Het optreden van lymfklierverkalkingen bij de ziekte van Hodgkin is een prognostisch gunstig teken. 7. Het verrichten van een lymfografie na een abdominale CT-scan levert alleen additionele informatie op wanneer de CT géén of twijfelachtige afwijkingen laat zien. 8. Magnetic Resonance Imaging (MRI) is een gevoelige methode voor het opsporen van afwijkingen in het been- merg bij patienter, met leukemie, maligne lymfoom of metastasen. (DO Oison et al., Invest. Radiol. 1986; 21: 540-546). 9. Wanneer bij patiënten met een niet-seminomateuza testistumor wordt gekozen voor een zogenaamd "wait and see" beleid, dan dient bij screening op retroperitone- ale lymfkliermetastasen zowel een abdominale CT-scan als een lymfografie te worden verricht. 10. Bij de bepaling van de resectabiliteit van een pancreastumor kan een percutané transhepatische porto- grafie (PTP) bij een groot deel van de patiënten worden vermeden door het uitvoeren van een intra-arteriële digitale subtractie angiografie (i.a. -
Iranian Journal of Nuclear Medicine
IRANIAN JOURNAL OF NUCLEAR MEDICINE Iranian Journal of Nuclear Medicine is a peer-reviewed biannually journal of the Research Institute for Nuclear Medicine, Tehran University of Medical Sciences, covering basic and clinical nuclear medicine sciences and relevant application. The journal has been published in Persian (Farsi) from 1993 to 1994, in English and Persian with English abstract from 1994 to 2008 and only in English language form the early of 2008 two times a year. The journal has an international editorial board and accepts manuscripts from scholars working in different countries. Chairman & Chief Editor: Saghari, Mohsen; MD Associate Editor and Executive Manager: Beiki, Davood; PhD Scientific Affairs: Eftekhari, Mohammad; MD and Fard-Esfahani, Armaghan; MD Editorial Board Alavi, Abbas; MD (USA) Grammaticos, Philip C.; MD (Greece) Ay, Mohammad Reza; PhD (Iran) Mirzaei, Siroos; MD (Austria) Beheshti, Mohsen; MD (Austria) Najafi, Reza; PhD (Iran) Beiki, Davood; PhD (Iran) Rahmim, Arman; PhD (USA) Cohen, Philip; MD (Canada) Rajabi, Hossein; PhD (Iran) Dabiri-Oskooei, Shahram; MD (Iran) Saghari, Mohsen; MD (Iran) Eftekhari, Mohammad; MD (Iran) Sarkar, Saeed; PhD (Iran) Fard-Esfahani, Armaghan; MD (Iran) Zakavi, Seyed Rasoul; MD (Iran) ------------------------------------------------------------------------------------------------------- Editorial Office Iranian Journal of Nuclear Medicine, Research Institute for Nuclear Medicine, Shariati Hospital, North Kargar Ave. 1411713135, Tehran, Iran Tel: ++98 21 88633333, 4 Fax: ++98 21 88026905 E-mail: [email protected] Website: http://irjnm.tums.ac.ir Indexed in/Abstracted by EMBASE, Scopus, ISC, DOAJ, Index Copernicus, EBSCO, IMEMR, SID, IranMedex, Magiran Vol 20 , Supplement 1 2012 INSTRUCTION TO AUTHORS Aims and Scope Review articles Iranian Journal of Nuclear Medicine is a peer-reviewed biannually These are, in general, invited papers, but unsolicited reviews, if of journal of the Research Institute for Nuclear Medicine, Tehran good quality, may be considered. -
Snomed Ct Dicom Subset of January 2017 Release of Snomed Ct International Edition
SNOMED CT DICOM SUBSET OF JANUARY 2017 RELEASE OF SNOMED CT INTERNATIONAL EDITION EXHIBIT A: SNOMED CT DICOM SUBSET VERSION 1. -
Full Prescribing Information for Surgery and Until Adequate Wound Healing
HIGHLIGHTS OF PRESCRIBING INFORMATION Risk of Impaired Wound Healing: Withhold QINLOCK for at least 1 week These highlights do not include all the information needed to use prior to elective surgery. Do not administer for at least 2 weeks after major QINLOCK safely and effectively. See full prescribing information for surgery and until adequate wound healing. The safety of resumption of QINLOCK. QINLOCK after resolution of wound healing complications has not been established. (5.5) QINLOCK™ (ripretinib) tablets, for oral use Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of Initial U.S. Approval: 2020 reproductive potential of the potential risk to a fetus and to use effective ----------------------------INDICATIONS AND USAGE--------------------------- contraception. (5.6, 8.1, 8.3) QINLOCK is a kinase inhibitor indicated for the treatment of adult patients -------------------------------ADVERSE REACTIONS------------------------------ with advanced gastrointestinal stromal tumor (GIST) who have received prior The most common adverse reactions (≥20%) were alopecia, fatigue, nausea, treatment with 3 or more kinase inhibitors, including imatinib. (1) abdominal pain, constipation, myalgia, diarrhea, decreased appetite, palmar ------------------------DOSAGE AND ADMINISTRATION---------------------- plantar erythrodysesthesia, and vomiting. The most common Grade 3 or 4 Recommended Dosage: 150 mg orally once daily with or without food. (2.1) laboratory abnormalities (≥4%) were increased lipase and decreased phosphate. (6.1) ----------------------DOSAGE