DOCSLIB.ORG

2019 Biomedtracker Datamonitor Healthcare ASCO Planner

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
2019 Biomedtracker Datamonitor Healthcare ASCO Planner AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING 2018 Pre-ASCOCHICAGO, Report ILLINOIS • MAY 31 – JUNE 4, 2019 Cover page, paste image over entire page 2019 ASCO Planner May 2018 / 1 Information Classification: General NOT A PRODUCT SPONSORED BY ASCO 2019 ASCO Annual Meeting Planner Friday, May 31 - Oral Presentations Start End Title Drug Company Presenter Abstract # Clinical Science Symposium EGFR and ROS1: Targeting Resistance Location: Hall D1 1:00 PM 2:30 PM Chair - EGFR and ROS1: Targeting Resistance Gregory J. Riely 1:00 PM 2:30 PM Chair - EGFR and ROS1: Targeting Resistance Jose Maria Pacheco 1:00 PM 1:12 PM How Can We Overcome TKI Resistance in EGFR-Mutant NSCLC? Katerina A. Politi 1:12 PM 1:24 PM JNJ-61186372 (JNJ-372), an EGFR-cMet bispecific antibody, in EGFR-driven advanced non-small cell JNJ-61186372 Johnson & Johnson Eric B. Haura 9009 lung cancer (NSCLC). 1:24 PM 1:36 PM Safety and preliminary antitumor activity of U3-1402: A HER3-targeted antibody drug conjugate in U3-1402 Daiichi Sankyo Pasi A. Janne 9010 EGFR TKI-resistant, EGFRm NSCLC. 1:36 PM 1:48 PM Using Antibodies in a TKI World Jessica Ruth Bauman 1:48 PM 2:00 PM Safety and preliminary clinical activity of repotrectinib in patients with advanced ROS1 fusion- repotrectinib Turning Point Byoung Chul Cho 9011 positive non-small cell lung cancer (TRIDENT-1 study). Therapeutics 2:00 PM 2:12 PM cROS1ng Barriers in Resistance Benjamin Besse 2:12 PM 2:30 PM Panel Question and Answer Panel Discussion Oral Abstract Session Genitourinary (Prostate) Cancer Location: Arie Crown Theater 2:45 PM 5:45 PM Chair - Genitourinary (Prostate) Cancer Joshi J. Alumkal 2:45 PM 5:45 PM Chair - Genitourinary (Prostate) Cancer Alan Haruo Bryce 2:45 PM 2:57 PM Impact of darolutamide (DARO) on pain and quality of life (QoL) in patients (Pts) with nonmetastatic darolutamide Bayer Karim Fizazi 5000 castrate-resistant prostate cancer (nmCRPC). 2:57 PM 3:09 PM Interest of short hormonotherapy (HT) associated with radiotherapy (RT) as salvage treatment for Christian Carrie 5001 metastatic free survival (MFS) after radical prostatectomy (RP): Update at 9 years of the GETUG-AFU 16 phase III randomized trial (NCT00423475). 3:09 PM 3:21 PM PSMA heterogeneity and DNA repair defects in prostate cancer. Alec Paschalis 5002 3:21 PM 3:33 PM Therapeutic Advances, Balancing Quality of Life Daniel Eidelberg Spratt 3:33 PM 3:45 PM Panel Question and Answer Panel Discussion 3:45 PM 3:57 PM Updated results from a randomized phase II study of cabazitaxel (CAB) versus abiraterone (ABI) or Jevtana; Xtandi; Sanofi; Astellas; Kim N. Chi 5003 enzalutamide (ENZ) in poor prognosis metastatic CRPC. Zytiga Johnson & Johnson 3:57 PM 4:09 PM TAXOMET: A French prospective multicenter randomized controlled phase II study comparing MARC Pujalte Martin 5004 docetaxel plus metformin versus docetaxel plus placebo in mCRPC. 4:09 PM 4:21 PM TOPARP-B: A phase II randomized trial of the poly(ADP)-ribose polymerase (PARP) inhibitor olaparib Lynparza AstraZeneca Joaquin Mateo 5005 for metastatic castration resistant prostate cancers (mCRPC) with DNA damage repair (DDR) alterations. 4:21 PM 4:33 PM Aggressive Therapy for Aggressive Disease Mary-Ellen Taplin 4:33 PM 4:45 PM Panel Question and Answer Panel Discussion 4:45 PM 4:57 PM First results from TITAN: A phase III double-blind, randomized study of apalutamide (APA) versus Erleada Johnson & Johnson Kim N. Chi 5006 placebo (PBO) in patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC) receiving androgen deprivation therapy (ADT). 4:57 PM 5:09 PM Decreased fracture rate by mandating bone-protecting agents in the EORTC 1333/PEACE III trial Xtandi; Xofigo Astellas; Bayer Bertrand F. Tombal 5007 comparing enzalutamide and Ra223 versus enzalutamide alone: An interim safety analysis. 5:09 PM 5:21 PM Alliance A031201: A phase III trial of enzalutamide (ENZ) versus enzalutamide, abiraterone, and Xtandi; Zytiga Astellas; Johnson & Michael J. Morris 5008 prednisone (ENZ/AAP) for metastatic castration resistant prostate cancer (mCRPC). Johnson 5:21 PM 5:33 PM Androgen Targeted Therapy: Is More Better? Michael Anthony 5:33 PM 5:45 PM Panel Question and Answer Panel Discussion Oral Abstract Session Head and Neck Cancer Location: E450 2:45 PM 5:45 PM Chair - Head and Neck Cancer Assuntina Gesualda Sacco 2:45 PM 5:45 PM Chair - Head and Neck Cancer Xiuning Le 2:45 PM 2:57 PM Protocol-specified final analysis of the phase 3 KEYNOTE-048 trial of pembrolizumab (pembro) as first- Keytruda Merck & Co. Danny Rischin 6000 line therapy for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). 2:57 PM 3:09 PM Ado-trastuzumab emtansine in patients with HER2 amplified salivary gland cancers (SGCs): Results Kadcyla Roche Bob T. Li 6001 from a phase II basket trial. 3:09 PM 3:21 PM TPExtreme randomized trial: TPEx versus Extreme regimen in 1st line recurrent/metastatic head and Joel Guigay 6002 neck squamous cell carcinoma (R/M HNSCC). 3:21 PM 3:33 PM The Three Pillars of Systemic Therapy Vanita Noronha 3:33 PM 3:45 PM Panel Question and Answer Panel Discussion 3:45 PM 3:57 PM Gemcitabine and cisplatin (GP) induction chemotherapy (IC) plus concurrent chemoradiotherapy Jun Ma 6003 (CCRT) versus CCRT alone in locoregionally advanced nasopharyngeal carcinoma (NPC): A phase 3, multicenter, randomized controlled trial. 3:57 PM 4:09 PM Induction chemotherapy followed by concurrent chemoradiotherapy versus concurrent Ming-Yuan Chen 6004 chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: Long-term results of a phase 3 multicenter randomized controlled trial. 4:09 PM 4:21 PM Believe it or Not! Intensification of Therapy for Nasopharynx Cancer A. Dimitrios Colevas 4:21 PM 4:33 PM Panel Question and Answer Panel Discussion 4:33 PM 4:45 PM A phase II randomized trial for early-stage squamous cell carcinoma of the oropharynx: Radiotherapy Anthony Charles Nichols 6006 versus trans-oral robotic surgery (ORATOR). 4:45 PM 4:57 PM Neck dissections based on sentinel lymph node navigation versus elective neck dissections in early Yasuhisa Hasegawa 6007 oral cancers: A randomized, multicenter, non-inferiority trial. 2019 ASCO Annual Meeting Planner Friday, May 31 - Oral Presentations Start End Title Drug Company Presenter Abstract # 4:57 PM 5:09 PM Checkpoint inhibitors assessment in oropharynx cancer (CIAO): Safety and interim results. Imfinzi; AstraZeneca Renata Ferrarotto 6008 tremelimumab 5:09 PM 5:21 PM Three Ways That Less May Be More: Deintensifying Surgery St. John Maie 5:21 PM 5:33 PM Panel Question and Answer Panel Discussion Oral Abstract Session Health Services Research, Clinical Informatics, and Quality of Care Location: S102 2:45 PM 5:45 PM Chair - Health Services Research, Clinical Informatics, and Quality of Care Jimmy Ruiz 2:45 PM 5:45 PM Chair - Health Services Research, Clinical Informatics, and Quality of Care Erica T. Warner 2:45 PM 2:57 PM Effect of montelukast and rupatadine on rituximab infusion time, rate, severity of reactions, and cost Singulair; Rupafin; Merck & Co.; Uriach; Rouslan Kotchetkov 6500 of administration. Rituxan Roche 2:57 PM 3:09 PM Comparison of normal saline versus heparin flush solutions for maintaining patency of central Amy Pai 6501 venous catheter in cancer patients. 3:09 PM 3:21 PM Preventing excess narcotic prescriptions in MIS urologic oncology discharges (PENN): A prospective Ruchika Talwar 6502 cohort quality improvement initiative. 3:21 PM 3:33 PM Significance of examined lymph node number in accurate staging and long-term survival in resected Lei Huang 6503 stage I-II pancreatic cancer: More is better? A large international population-based cohort study. 3:45 PM 3:57 PM Panel Question and Answer Panel Discussion 3:57 PM 4:09 PM Economic analysis of alternative pembrolizumab and nivolumab dosing strategies at an academic Keytruda; Opdivo Merck & Co.; Bristol- Evan Thomas Hall 6504 cancer center. Myers Squibb 4:09 PM 4:21 PM A process to reduce hospital admissions in the OCM population through focused intervention of Manuel Perry 6505 super-utilizers. 4:21 PM 4:33 PM The financial impact of physician practice patterns: An analysis of as-needed filgrastim versus Christine Barrett 6506 prophylactic pegfilgrastim in patients with prostate cancer receiving docetaxel. 4:33 PM 4:45 PM Costs Matter: Strategies for Success Kerin B. Adelson 4:45 PM 4:57 PM Panel Question and Answer Panel Discussion 4:57 PM 5:09 PM Quality of end-of-life cancer care at minority-serving US cancer centers: A retrospective study of Garrett Wasp 6507 Medicare claims data. 5:09 PM 5:21 PM Impact of a same-day breast biopsy program on disparities in time to biopsy. Matthew Seidler 6508 5:21 PM 5:33 PM Disparities: Measurement to Action Erica T. Warner 5:33 PM 5:45 PM Panel Question and Answer Panel Discussion Oral Abstract Session Pediatric Oncology I Location: S504 2:45 PM 5:45 PM Chair - Pediatric Oncology I Margaret E Macy 2:45 PM 5:45 PM Chair - Pediatric Oncology I Melinda Gordon Pauly 2:45 PM 2:57 PM Randomized phase 2 trial of the combination of vincristine and irinotecan with or without Anne Sophie 10000 temozolomide, in children and adults with refractory or relapsed rhabdomyosarcoma (RMS). Defachelles 2:57 PM 3:09 PM Temozolomide versus irinotecan-temozolomide for children with relapsed and refractory high risk Lucas Moreno 10001 neuroblastoma (RR-HRNB): Results of the BEACON-Neuroblastoma randomized phase 2 trial—A European Innovative Therapies for Children with Cancer (ITCC) - International Society of Pediatric Oncology Europe Neuroblastoma Group (SIOPEN) trial. 3:09 PM 3:21 PM Chemotherapy Combinations for Solid Tumors: The Whole Is Not Greater Than the Sum of the Parts Lars M.
Load more

Recommended publications
  • 2015 Post-ASH Report
    Datamonitor Healthcare Trialtrove Biomedtracker Pharma intelligence | Pharma intelligence | Pharma intelligence | 2015 Post-ASH Report RACHEL MEIGHAN-MANTHA Principal Analyst, Citeline JOSEPH HEDDEN Senior Analyst, Datamonitor Healthcare Summary Profiled themes at the 57th Annual Meeting and Exposition of the American Society of Hematology (ASH), held December 5-8, 2015, in Orlando, Florida, included Genomic Profiling and Chemical Biology, Genome Editing and Gene Therapy, Epigenetic Mechanisms, Immunologic Treatments, Stem Cell Biology and Regenerative Medicine and Preventing Venous Thromboembolic Disease. This report will mainly focus on the theme of Immunologic Treatments because of the importance and popularity of immunotherapies for many different hematological cancers. Also covered in this report are the results from pivotal trials presented at ASH, as well as highlights from other drugs/therapies of interest. In addition, we felt it was important to cover first-in-human trials since (hopefully) some of these drugs/therapies will be in pivotal trials in a few years. At the end of the report, we’ve included a section showcasing drugs that had top- line results presented at ASH, followed by a list of other data presentations supplied by BioMedTracker (BMT). Accompanying links to BioMedTracker events along with changes to the drugs’ likelihood of approval (LOA) are also provided throughout the report. Finally, additional supplemental material related to ASH is listed in the Appendix. 2 Datamonitor Healthcare Trialtrove Biomedtracker
    [Show full text]
  • Tanibirumab (CUI C3490677) Add to Cart
    5/17/2018 NCI Metathesaurus Contains Exact Match Begins With Name Code Property Relationship Source ALL Advanced Search NCIm Version: 201706 Version 2.8 (using LexEVS 6.5) Home | NCIt Hierarchy | Sources | Help Suggest changes to this concept Tanibirumab (CUI C3490677) Add to Cart Table of Contents Terms & Properties Synonym Details Relationships By Source Terms & Properties Concept Unique Identifier (CUI): C3490677 NCI Thesaurus Code: C102877 (see NCI Thesaurus info) Semantic Type: Immunologic Factor Semantic Type: Amino Acid, Peptide, or Protein Semantic Type: Pharmacologic Substance NCIt Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor tyrosine kinase expressed by endothelial cells, while VEGF is overexpressed in many tumors and is correlated to tumor progression. PDQ Definition: A fully human monoclonal antibody targeting the vascular endothelial growth factor receptor 2 (VEGFR2), with potential antiangiogenic activity. Upon administration, tanibirumab specifically binds to VEGFR2, thereby preventing the binding of its ligand VEGF. This may result in the inhibition of tumor angiogenesis and a decrease in tumor nutrient supply. VEGFR2 is a pro-angiogenic growth factor receptor
    [Show full text]
  • Eflapegrastim-Xnst Submitted by Spectrum Pharmaceuticals
    Anton F. Ehrhardt, PhD, VP Medical Affairs Spectrum Pharmaceuticals, Inc One Main St, 11th floor Cambridge, MA 02142 Phone: (617) 477-8091 Email: [email protected] Date of request: 31 August 2020 NCCN Guidelines Panel: Hematopoietic Growth Factors On behalf of Spectrum Pharmaceuticals, Inc., I respectfully request the NCCN Hematopoietic Growth Factors Panel review the enclosed data for inclusion of eflapegrastim-xnst (Rolontis®), a non-biosimilar long-acting G- CSF of noVel structure, as a recommendation for prophylaxis of febrile neutropenia and maintenance of scheduled dose deliVery (MGF-B). Specific Changes: 1. Addition of eflapegrastim-xnst as a recommendation for prophylaxis of febrile neutropenia and maintenance of scheduled dose deliVery (MGF-B) a. Dosing recommendation below listing of eflapegrastim-xnst: One dose of 13.2 mg (MGF-B) 2. Addition of eflapegrastim-xnst to the listing of Filgrastim, Pegfilgrastim and Tbo-filgrastim in table MGF- D (Toxicity Risks for Myeloid Growth Factors) FDA Clearance: Rolontis is undergoing FDA reView based on an original BLA#761148 for a proposed indication of: to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. PDUFA for this reView is October 24th, 2020. Rationale: In support of the proposed change, data were generated in pre-clinical in-Vitro and animal model studies that indicated structure-related enhancement of potency, and increased concentrations in bone marrow compared to pegfilgrastim (Barrett 2020(reference 1)). Eflapegrastim is composed of a recombinant human G- CSF joined to an IgG4 Fc moiety Via a short polyethylene glycol linker.
    [Show full text]
  • WO 2018/102397 Al 07 June 2018 (07.06.2018) W !P O PCT
    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2018/102397 Al 07 June 2018 (07.06.2018) W !P O PCT (51) International Patent Classification: John; 64 Gray Street, Arlington, Massachusetts 02476 A61K 9/133 (2006.01) A61K 9/10 (2006.01) (US). MUTAMBA, James Tendai; 70 Longfellow Road, A61K 9/127 {2006.01) Newton, Massachusetts 02462 (US). SHYAM, Rishab R.; 995 Massachusetts Avenue, Arlington, Massachusetts (21) International Application Number: 02476 (US). PCT/US2017/063681 (74) Agent: RED), Andrea L.C. et al; One International (22) International Filing Date: Place, 40th Floor, 100 Oliver Street, Boston, Massachusetts 29 November 201 7 (29. 11.201 7) 021 10-2605 (US). (25) Filing Language: English (81) Designated States (unless otherwise indicated, for every (26) Publication Langi English kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, (30) Priority Data: CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, 62/427,53 1 29 November 2016 (29. 11.2016) US DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, 62/559,921 18 September 2017 (18.09.2017) US HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, 62/559,967 18 September 2017 (18.09.2017) US KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, (71) Applicant: PURETECH HEALTH LLC [US/US]; 501 MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, Boylston Street, Suite 6102, Boston, Massachusetts 021 16 OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, (US).
    [Show full text]
  • Pre-Clinical Specificity and Safety of UC-961, a First-In-Class Monoclonal Antibody Targeting ROR1
    SOHO Supplement 2015 Pre-clinical Specificity and Safety of UC-961, a First-In-Class Monoclonal Antibody Targeting ROR1 Michael Y. Choi,1 George F. Widhopf II,1 Christina C.N. Wu,1 Bing Cui,1 Fitzgerald Lao,1 Anil Sadarangani,1,2 Joy Cavagnaro,3 Charles Prussak,1 Dennis A. Carson,1 Catriona Jamieson,1,2 Thomas J. Kipps1 Abstract Receptor tyrosine kinase-like orphan receptor 1 (ROR1) is an oncoembryonic antigen. Because of its expression on the cell surface of leukemia cells from patients with chronic lymphocytic leukemia (CLL), but not on normal B-cells or other postpartum tissues, ROR1 is an attractive candidate for targeted therapies. UC-961 is a first-in-class humanized monoclonal antibody that binds the extracellular domain of ROR1. In this article we outline some of the preclinical studies leading to an investigational new drug designation, enabling clinical studies in patients with CLL. Clinical Lymphoma, Myeloma & Leukemia, Vol. 15, No. S1, S167-9 ª 2015 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/) Keywords: AKT, cancer stem cell, Cirmtuzumab, CLL, Wnt receptor Receptor Tyrosine Kinase-Like normal B lymphocytes.5,6 Analysis of autoantibodies produced Orphan Receptor 1 Is an by patients immunized with autologous leukemia cells transduced Oncoembryonic Antigen Not to express CD154 identified that these autoantibodies recognized Expressed by Normal Postpartum ROR1 protein on the leukemia cell surface.7 Functional studies Tissues
    [Show full text]
  • Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
    HEMATOLOGIC MALIGNANCIES—LYMPHOMA AND CHRONIC LYMPHOCYTIC LEUKEMIA 7500 Oral Abstract Session First results of a head-to-head trial of acalabrutinib versus ibrutinib in previously treated chronic lymphocytic leukemia. John C. Byrd, Peter Hillmen, Paolo Ghia, Arnon P. Kater, Asher Alban Akmal Chanan-Khan, Richard R. Furman, Susan M. O’Brien, Mustafa Nuri Yenerel, A�rpa�d Ille�s, Neil E. Kay, Jose Antonio Garcia Marco, Anthony R. Mato, John Francis Seymour, Stephane Lepre^tre, Stephan Stilgenbauer, Tadeusz Robak, Priti Patel, Kara Higgins, Sophia Sohoni, Wojciech Jurczak; The Ohio State University Wexner Medical Center, Columbus, OH; St. James’s University Hospital, Leeds, United Kingdom; Universita� Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele, Milan, Italy; Amsterdam University Medical Center, Amsterdam, on behalf of Hovon, Amsterdam, Netherlands; Mayo Clinic, Jacksonville, FL; Weill Cornell Medicine, New York Presbyterian Hospital, New York, NY; Chao Family Comprehensive Cancer Center, University of California, Irvine, CA; Liv Hospital Ulus, Besiktas, Turkey; University of Debrecen, Debre- cen, Hungary; Mayo Clinic, Rochester, MN; Hospital Universitario Puerta de Hierro-Majadahonda, Ma- drid, Spain; University of Pennsylvania, Philadelphia, PA; Peter MacCallum Cancer Centre & Royal Melbourne Hospital, Melbourne, Australia; Centre Henri Becquerel and Normandie University UNI- ROUEN, Rouen, France; University of Ulm, Ulm, Germany; Medican University of Lodz, Lodz, Poland; AstraZeneca, South San Francisco, CA; Maria Sklodowska-Curie National Research Institute of Oncolo- gy, Krakow, Poland Background: Increased selectivity of the Bruton tyrosine kinase inhibitor (BTKi) acalabrutinib (Aca) vs ibrutinib (Ib) may improve tolerability. We conducted an open-label, randomized, noninferiority, phase 3 trial to compare Aca vs Ib in patients (pts) with chronic lymphocytic leukemia (CLL).
    [Show full text]
  • Drug Utilization R Eview B Oard
    OHCA Webinar Wednesday, March 10, 2021 Review Board 4:00pm Please register for the webinar at: https://zoom.us/s/97305655255 After registering, you will receive a confirmation email containing information about joining the webinar. Drug Utilization The University of Oklahoma Health Sciences Center COLLEGE OF PHARMACY PHARMACY MANAGEMENT CONSULTANTS MEMORANDUM TO: Drug Utilization Review (DUR) Board Members FROM: Michyla Adams, Pharm.D. SUBJECT: Packet Contents for DUR Board Meeting – March 10, 2021 DATE: February 22, 2021 NOTE: In response to COVID-19, the March 2021 DUR Board meeting will be held via OHCA webinar at 4:00pm. Please register for the meeting using the following website address: https://zoom.us/s/97305655255 After registering, you will receive a confirmation email containing information about joining the webinar. Enclosed are the following items related to the March meeting. Material is arranged in order of the agenda. Call to Order Public Comment Forum Action Item – Approval of DUR Board Meeting Minutes – Appendix A Quarterly Review of the Medication Therapy Management (MTM) Program – Appendix B Update on Medication Coverage Authorization Unit/Spring 2021 Pipeline Update – Appendix C Action Item – Vote to Prior Authorize Anjeso® (Meloxicam Injection) and Licart™ (Diclofenac Epolamine Topical System) – Appendix D Action Item – Vote to Prior Authorize Oxlumo™ (Lumasiran) – Appendix E Action Item – Vote to Prior Authorize Fintepla® (Fenfluramine) – Appendix F Action Item – Vote to Prior Authorize Teriparatide – Appendix G
    [Show full text]
  • Role of Non-Coding Rnas in the Development of Targeted Therapy and Immunotherapy Approaches for Chronic Lymphocytic Leukemia
    Journal of Clinical Medicine Review Role of Non-Coding RNAs in the Development of Targeted Therapy and Immunotherapy Approaches for Chronic Lymphocytic Leukemia Felice Pepe 1,2 and Veronica Balatti 1,2,* 1 Department of Cancer Biology and Medical Genetics, The Ohio State University, Columbus, OH 43210, USA; [email protected] 2 The Ohio State University Comprehensive Cancer Center, The Ohio State University, Columbus, OH 43210, USA * Correspondence: [email protected]; Tel.: +1-614-292-0654 Received: 31 December 2019; Accepted: 16 February 2020; Published: 21 February 2020 Abstract: In the past decade, novel targeted therapy approaches, such as BTK inhibitors and Bcl2 blockers, and innovative treatments that regulate the immune response against cancer cells, such as monoclonal antibodies, CAR-T cell therapy, and immunomodulatory molecules, have been established to provide support for the treatment of patients. However, drug resistance development and relapse are still major challenges in CLL treatment. Several studies revealed that non-coding RNAs have a main role in the development and progression of CLL. Specifically, microRNAs (miRs) and tRNA-derived small-RNAs (tsRNAs) were shown to be outstanding biomarkers that can be used to diagnose and monitor the disease and to possibly anticipate drug resistance and relapse, thus supporting physicians in the selection of treatment regimens tailored to the patient needs. In this review, we will summarize the most recent discoveries in the field of targeted therapy and immunotherapy for CLL and discuss the role of ncRNAs in the development of novel drugs and combination regimens for CLL patients. Keywords: CLL; mir-15/16; venetoclax; targeted therapy; immunotherapy 1.
    [Show full text]
  • CLL June 18 2014 Slides
    CLL Current and Emerging Therapies Welcome and Introductions June 18, 2014 CLL Current and Emerging Therapies Thomas J. Kipps, MD, PhD Professor of Medicine Division of Hematology-Oncology Deputy Director for Research UC San Diego Moores Cancer Center La Jolla, CA June 18, 2014 1 CLL Current and Emerging Therapies Disclosures Dr. Kipps does not have any relevant financial relationships with any commercial interests to disclose. June 18, 2014 2 Chronic Lymphocytic Leukemia (CLL) • Clinical course of pts with CLL is highly variable • Many pts are asymptomatic at diagnosis • CLL still is considered incurable with current therapy • Therapy may cause morbidity or mortality • Current recommendations are to withhold therapy until pts develop disease-related – Symptoms (e.g. fatigue, wt. loss) – Complications (e.g. impaired marrow or immune function) CLL Prognostic Markers Mutated vs Unmutated IGHV Genes Overall Survival 100 All Patients 100 Binet Stage A Patients (N=84) (n=62) 80 80 Mutated 60 Mutated 60 Surviving, % Surviving, 40 P=0.001 40 P=0.0008 Surviving, % Surviving, Unmutated 20 Unmutated 20 0 0 0 50 100 150 200 250 300 0 50 100 150 200 250 300 Months Months CLL, chronic lymphocytic leukemia. Hamblin TJ, et al. Blood. 94:1848-1854, 1999 3 Approved Drugs For Treatment of Patients with Chronic Lymphocytic Leukemia • Steroids (e.g. prednisone) Kinase Inhibitors • Ibrutinib • Classic Chemotherapy – Alkylating Agents • Chlorambucil Monoclonal Antibodies • Cyclophosphamide (C) • Alemtuzumab • Bendamustine (B) • Ofatumumab – Purine Analogs •
    [Show full text]
  • A Abacavir Abacavirum Abakaviiri Abagovomab Abagovomabum
    A abacavir abacavirum abakaviiri abagovomab abagovomabum abagovomabi abamectin abamectinum abamektiini abametapir abametapirum abametapiiri abanoquil abanoquilum abanokiili abaperidone abaperidonum abaperidoni abarelix abarelixum abareliksi abatacept abataceptum abatasepti abciximab abciximabum absiksimabi abecarnil abecarnilum abekarniili abediterol abediterolum abediteroli abetimus abetimusum abetimuusi abexinostat abexinostatum abeksinostaatti abicipar pegol abiciparum pegolum abisipaaripegoli abiraterone abirateronum abirateroni abitesartan abitesartanum abitesartaani ablukast ablukastum ablukasti abrilumab abrilumabum abrilumabi abrineurin abrineurinum abrineuriini abunidazol abunidazolum abunidatsoli acadesine acadesinum akadesiini acamprosate acamprosatum akamprosaatti acarbose acarbosum akarboosi acebrochol acebrocholum asebrokoli aceburic acid acidum aceburicum asebuurihappo acebutolol acebutololum asebutololi acecainide acecainidum asekainidi acecarbromal acecarbromalum asekarbromaali aceclidine aceclidinum aseklidiini aceclofenac aceclofenacum aseklofenaakki acedapsone acedapsonum asedapsoni acediasulfone sodium acediasulfonum natricum asediasulfoninatrium acefluranol acefluranolum asefluranoli acefurtiamine acefurtiaminum asefurtiamiini acefylline clofibrol acefyllinum clofibrolum asefylliiniklofibroli acefylline piperazine acefyllinum piperazinum asefylliinipiperatsiini aceglatone aceglatonum aseglatoni aceglutamide aceglutamidum aseglutamidi acemannan acemannanum asemannaani acemetacin acemetacinum asemetasiini aceneuramic
    [Show full text]
  • 2018 Medicines in Development for Cancer
    2018 Medicines in Development for Cancer Bladder Cancer Product Name Sponsor Indication Development Phase ABI-009 AADi Bioscience non-muscle invasive bladder cancer Phase I/II (nab-rapamycin/mTOR inhibitor) Los Angeles, CA www.aadibio.com ALT-801 Altor BioScience non-muscle invasive bladder cancer Phase I/II (tumor antigen-specific T-cell Miramar, FL www.altorbioscience.com receptor linked to IL-2) NantKwest Culver City, CA ALT-803 Altor BioScience non-muscle invasive bladder cancer Phase II (IL-15 superagonist protein complex) Miramar, FL (BCG naïve) (Fast Track), www.altorbioscience.com NantKwest non-muscle invasive bladder cancer Culver City, CA (BCG unresponsive) (Fast Track) B-701 BioClin Therapeutics 2L locally advanced or metastatic Phase I/II (anti-FGFR3 mAb) San Ramon, CA bladder cancer www.bioclintherapeutics.com Bavencio® EMD Serono 1L urothelial cancer Phase III avelumab Rockland, MA www.emdserono.com (anti-PD-L1 inhibitor) Pfizer www.pfizer.com New York, NY BC-819 BioCanCell Therapeutics non-muscle invasive bladder cancer Phase II (gene therapy) Cambridge, MA (Fast Track) www.biocancell.com Medicines in Development: Cancer ǀ 2018 1 Bladder Cancer Product Name Sponsor Indication Development Phase Capzola® Spectrum Pharmaceuticals non-muscle invasive bladder cancer application submitted apaziquone Henderson, NV (Fast Track) www.sppirx.com Cavatak® Viralytics bladder cancer (+pembrolizumab) Phase I coxsackievirus Sydney, Australia www.viralytics.com CG0070 Cold Genesys non-muscle invasive bladder cancer Phase II (oncolytic immunotherapy)
    [Show full text]
  • Korea Innovative PHARMACEUTICAL Company Potential of Pharmaceutical Industry in Korea
    2017 Korea Innovative PHARMACEUTICAL Company Potential of Pharmaceutical Industry in Korea Aging populations and growing interest in health and welfare continue companies have developed therapies in an array of areas including oncology, antibacterial, gastritis, respiratory to drive up the demand for innovative drugs across the world. Globally, infections, duodenal ulcer, diabetic foot ulcer, erectile dysfunction, hepatitis B and hypertension. R&D spending in the pharmaceutical industry was higher than any Development of innovative drugs targeting other industry (pharmaceutical and bio ranked No. 1 with 150 billion Drug development the global market Early years of drug getting on track 2010’s dollars(2015)), indicating that the future industrial structure is shifting Development of development Local manufacturing of 2000’s finished products and new processes from IT to pharmaceutical business. drug substance 1990’s 1980’s 1960/70’s Pharmaceutical Industry in Korea Launch of innovative drugs(total of 27) ’99 ’01 ’02 ’03 ’05 ’06 ’07 ’08 ’10 ’12 ’13 ’14 ’15 2016 In Korean, the value of drugs manufactured in Korea was KRW 16.9 trillion in 2015. The annual average growth rate for the past five years was 4.7 percent. In addition, the size of the pharmaceutical market was KRW 19.2 trillion in 2015. Sunpla EGF Factive Apitoxin Revanex Levovir Pelubi Noltec Pyramax Supect Duvie Riavax Acelex Olita Tab Milican Peudovaccin Zydena Mvix Kanab Zemiglo Zabolante Size and Market Trends in Pharmaceutical Industry in Korea (Unit: KRW Trillion, %) Category
    [Show full text]