NICE TA Adherence Checklist 2018/19

Total Page:16

File Type:pdf, Size:1020Kb

NICE TA Adherence Checklist 2018/19 Technology appraisal (TA) Date of TA Adherence of local formulary to NICE Release Included on the Trust Formulary for this Reason provided if "No" indication Yes OR No 2018-19 27/03/2019 TA572 - Ertugliflozin as monotherapy or with metformin for treating type 2 diabetes Yes 20/03/2019 TA571 - Brigatinib for treating ALK-positive advanced non-small-cell lung cancer after crizotinib Yes 20/03/2019 TA570 - Pembrolizumab for treating recurrent or metastatic squamous cell carcinoma Terminated appraisal of the head and neck after platinum-based chemotherapy (terminated appraisal) No 20/03/2019 TA569 - Pertuzumab for adjuvant treatment of HER2-positive early stage breast cancer Yes 13/03/2019 TA568 - Abatacept for treating psoriatic arthritis after DMARDs (terminated appraisal) No Terminated appraisal 13/03/2019 TA567 - Tisagenlecleucel for treating relapsed or refractory diffuse large B-cell Not applicable to CWFT - Condition not lymphoma after 2 or more systemic therapies No treated at CWFT 07/03/2019 TA566 - Cochlear implants for children and adults with severe to profound deafness No Not applicable - Medical device 06/03/2019 TA565 - Benralizumab for treating severe eosinophilic asthma Yes 27/02/2019 TA564 - Dabrafenib with trametinib for treating advanced metastatic BRAF V600E Terminated appraisal mutation-positive non-small-cell lung cancer (terminated appraisal) No 27/02/2019 TA563 - Abemaciclib with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer Yes 27/02/2019 TA562 - Encorafenib with binimetinib for unresectable or metastatic BRAF V600 mutation-positive melanoma Yes 27/02/2019 TA561 - Venetoclax with rituximab for previously treated chronic lymphocytic leukaemia Yes 20/02/2019 TA560 - Bevacizumab with carboplatin, gemcitabine and paclitaxel for treating the first Terminated appraisal recurrence of platinum-sensitive advanced ovarian cancer (terminated appraisal) No 23/01/2019 TA559 - Axicabtagene ciloleucel for treating diffuse large B-cell lymphoma and primary Not applicable to CWFT - Condition not mediastinal large B-cell lymphoma after 2 or more systemic therapies No treated at CWFT 23/01/2019 TA558 - Nivolumab for adjuvant treatment of completely resected melanoma with lymph node involvement or metastatic disease Yes 10/01/2019 TA557 - Pembrolizumab with pemetrexed and platinum chemotherapy for untreated, metastatic, non-squamous non-small-cell lung cancer Yes 09/01/2019 TA556 - Darvadstrocel for treating complex perianal fistulas in Crohn’s disease No Not recommended 09/01/2019 Not applicable to CWFT - Condition not TA555 - Regorafenib for previously treated advanced hepatocellular carcinoma No treated at CWFT 21/12/2018 TA554 - Tisagenlecleucel for treating relapsed or refractory B-cell acute lymphoblastic Not applicable to CWFT - Condition not leukaemia in people aged up to 25 years No treated at CWFT 19/12/2018 TA553 - Pembrolizumab for adjuvant treatment of resected melanoma with high risk of recurrence Yes 19/12/2018 TA552 - Liposomal cytarabine–daunorubicin for untreated acute myeloid leukaemia Yes 19/12/2018 Not applicable to CWFT - Condition not TA551- Lenvatinib for untreated advanced hepatocellular carcinoma No treated at CWFT 12/12/2018 TA550 - Vandetanib for treating medullary thyroid cancer No Not recommended 05/12/2018 TA549 - Denosumab for preventing skeletal-related events in multiple myeloma Terminated appraisal (terminated appraisal) No 05/12/2018 TA548 - Decitabine for untreated acute myeloid leukaemia (terminated appraisal) No Terminated appraisal 28/11/2018 TA547 - Tofacitinib for moderately to severely active ulcerative colitis Yes 21/11/2018 TA546 - Padeliporfin for untreated localised prostate cancer No Not recommended 14/11/2018 TA545 - Gemtuzumab ozogamicin for untreated acute myeloid leukaemia Yes 17/10/2018 TA544 - Dabrafenib with trametinib for adjuvant treatment of resected BRAF V600 mutation-positive melanoma Yes 03/10/2018 TA543 - Tofacitinib for treating active psoriatic arthritis after inadequate response to DMARDs Yes 03/10/2018 TA542 - Cabozantinib for untreated advanced renal cell carcinoma Yes 19/09/2018 TA541 - Inotuzumab ozogamicin for treating relapsed or refractory B-cell acute Not applicable to CWFT - Condition not lymphoblastic leukaemia No treated at CWFT 03/09/2018 TA540 - Pembrolizumab for treating relapsed or refractory classical Hodgkin lymphoma Yes 29/08/2018 TA539 - Lutetium (177Lu) oxodotreotide for treating unresectable or metastatic Not applicable to CWFT - Condition not neuroendocrine tumours No treated at CWFT 22/08/2018 Not applicable to CWFT - Condition not TA538 - Dinutuximab beta for treating neuroblastoma No treated at CWFT 08/08/2018 TA537 - Ixekizumab for treating active psoriatic arthritis after inadequate response to DMARDs Yes 08/08/2018 TA536 - Alectinib for untreated ALK-positive advanced non-small-cell lung cancer Yes 08/08/2018 TA535 - Lenvatinib and sorafenib for treating differentiated thyroid cancer after Not applicable to CWFT - Condition not radioactive iodine No treated at CWFT 01/08/2018 TA534 - Dupilumab for treating moderate to severe atopic dermatitis Yes 25/07/2018 Not applicable to CWFT - Specialist TA533 - Ocrelizumab for treating relapsing–remitting multiple sclerosis No Centres only and CWFT is not a commissioning Centre 18/07/2018 TA532 - Cenegermin for treating neurotrophic keratitis No Not recommended 18/07/2018 TA531 - Pembrolizumab for untreated PD-L1-positive metastatic non-small-cell lung cancer Yes 04/07/2018 TA530 - Nivolumab for treating locally advanced unresectable or metastatic urothelial Not recommended cancer after platinum-containing chemotherapy No 04/07/2018 TA529 - Crizotinib for treating ROS1-positive advanced non-small-cell lung cancer Yes 04/07/2018 TA528 - Niraparib for maintenance treatment of relapsed, platinum-sensitive ovarian, Not applicable to CWFT - Condition not fallopian tube and peritoneal cancer No treated at CWFT 27/06/2018 TA527 - Beta interferons and glatiramer acetate for treating multiple sclerosis Yes 13/06/2018 Not applicable to CWFT - Condition not TA526 - Arsenic trioxide for treating acute promyelocytic leukaemia No treated at CWFT 13/06/2018 TA525 - Atezolizumab for treating locally advanced or metastatic urothelial carcinoma after platinum-containing chemotherapy Yes 13/06/2018 TA524 - Brentuximab vedotin for treating CD30-positive Hodgkin lymphoma Yes 13/06/2018 Not applicable to CWFT - Specialist TA523 - Midostaurin for untreated acute myeloid leukaemia No Centres only and CWFT is not a commissioning Centre 13/06/2018 TA522 - Pembrolizumab for untreated PD-L1-positive locally advanced or metastatic urothelial cancer when cisplatin is unsuitable Yes 13/06/2018 TA521 - Guselkumab for treating moderate to severe plaque psoriasis Yes 16/05/2018 TA520 - Atezolizumab for treating locally advanced or metastatic non-small-cell lung cancer after chemotherapy Yes 25/04/2018 TA519 - Pembrolizumab for treating locally advanced or metastatic urothelial carcinoma after platinum-containing chemotherapy Yes 18/04/2018 Not applicable to CWFT - Specialist TA518 - Tocilizumab for treating giant cell arteritis No Centres only and CWFT is not a commissioning Centre 11/04/2018 TA517 - Avelumab for treating metastatic Merkel cell carcinoma Yes.
Recommended publications
  • Formulary Adherence Checklist
    NICE Technology Appraisals About Medicines: Formulary Adherence Checklist This spreadsheet is updated monthly and enables self-audit of a medicines formulary for adherence to current NICE Technology Appraisals. All guidelines refer to adults unless indicated. No copyright is asserted on this material if used for non-commercial purposes within the NHS. Last updated 18-Jun-19 Technology appraisal Date of TA Availability of medicine for NHS patients with this medical condition, as indicated by (TA) Release NICE Adherence of local formulary to NICE Titles are hyperlinks to Yes N/A Date of local Date of local Time to full guidance (mark 'x' if (mark 'x' if decision decision implement applicable) applicable) Due (90 days) Made (days) 2018-19 TA517 Avelumab for Avelumab for treating metastatic Merkel cell carcinoma. 1 treating metastatic 11/04/2018 Evidence-based recommendations on avelumab (Bavencio) for treating metastatic X 10/07/2018 17/12/2018 250 Merkel cell carcinoma (secondary) Merkel cell carcinoma in adults. TA518 Tocilizumab for Tocilizumab for treating giant cell arteritis. 1 treating giant cell 18/04/2018 Evidence-based recommendations on tocilizumab (RoActemra) for treating giant cell X 17/07/2018 16/07/2018 89 arteritis arteritis in adults. Pembrolizumab for treating locally advanced or metastatic urothelial carcinoma after TA519 Pembrolizumab platinum-containing chemotherapy. for treating locally Evidence-based recommendations on pembrolizumab (Keytruda) for previously advanced or metastatic treated locally advanced or metastatic urothelial carcinoma in adults. 1 urothelial carcinoma 25/04/2018 X 24/07/2018 04/05/2018 9 after platinum- containing chemotherapy TA520 - Atezolizumab Evidence-based recommendations on atezolizumab (Tecentriq) for locally advanced for treating locally or metastatic non-small-cell lung cancer after chemotherapy in adults.
    [Show full text]
  • EAU-EANM-ESUR-ESTRO-SIOG Guidelines on Prostate Cancer 2019
    EAU - EANM - ESTRO - ESUR - SIOG Guidelines on Prostate Cancer N. Mottet (Chair), R.C.N. van den Bergh, E. Briers (Patient Representative), P. Cornford (Vice-chair), M. De Santis, S. Fanti, S. Gillessen, J. Grummet, A.M. Henry, T.B. Lam, M.D. Mason, T.H. van der Kwast, H.G. van der Poel, O. Rouvière, D. Tilki, T. Wiegel Guidelines Associates: T. Van den Broeck, M. Cumberbatch, N. Fossati, T. Gross, M. Lardas, M. Liew, L. Moris, I.G. Schoots, P-P.M. Willemse © European Association of Urology 2019 TABLE OF CONTENTS PAGE 1. INTRODUCTION 9 1.1 Aims and scope 9 1.2 Panel composition 9 1.2.1 Acknowledgement 9 1.3 Available publications 9 1.4 Publication history and summary of changes 9 1.4.1 Publication history 9 1.4.2 Summary of changes 9 2. METHODS 12 2.1 Data identification 12 2.2 Review 13 2.3 Future goals 13 3. EPIDEMIOLOGY AND AETIOLOGY 13 3.1 Epidemiology 13 3.2 Aetiology 14 3.2.1 Family history / genetics 14 3.2.2 Risk factors 14 3.2.2.1 Metabolic syndrome 14 3.2.2.1.1 Diabetes/metformin 14 3.2.2.1.2 Cholesterol/statins 14 3.2.2.1.3 Obesity 14 3.2.2.2 Dietary factors 14 3.2.2.3 Hormonally active medication 15 3.2.2.3.1 5-alpha-reductase inhibitors 15 3.2.2.3.2 Testosterone 15 3.2.2.4 Other potential risk factors 15 3.2.3 Summary of evidence and guidelines for epidemiology and aetiology 16 4.
    [Show full text]
  • Single Technology Appraisal Padeliporfin for Treating Localised
    Single Technology Appraisal Padeliporfin for treating localised prostate cancer [ID866] Committee Papers © National Institute for Health and Care Excellence 2018. All rights reserved. See Notice of Rights. The content in this publication is owned by multiple parties and may not be re-used without the permission of the relevant copyright owner. NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE SINGLE TECHNOLOGY APPRAISAL Padeliporfin for treating localised prostate cancer [ID866] Contents: 1. Pre-Meeting Briefing 2. Final Scope and Final Matrix of Consultees and Commentators 3. Company submission from Steba Biotech 4. Clarification letters NICE request to the company for clarification on their submission Company response to NICE’s request for clarification 5. Patient group, professional group and NHS organisation submission from: British Association of Urological Surgeons 6. Expert statements from: Caroline Moore, clinical expert, nominated by British Association of Urological Surgeons Mark Emberton – clinical expert, nominated by Steba Biotech 7. Evidence Review Group report prepared by Aberdeen HTA Group 8. Evidence Review Group report – addendum Evidence Review Group report – factual accuracy check – the company stated that they did not identify any factual inaccuracies in the ERG report Any information supplied to NICE which has been marked as confidential, has been redacted. All personal information has also been redacted. © National Institute for Health and Care Excellence 2018. All rights reserved. See Notice of Rights. The content in this publication is owned by multiple parties and may not be re-used without the permission of the relevant copyright owner. Pre-meeting briefing Padeliporfin for treating localised prostate cancer [ID866] This slide set is the pre-meeting briefing for this appraisal.
    [Show full text]
  • NSCLC Therapeutics in Asia-Pacific Markets to 2019 Personalized Therapies Focus on Untapped Segment of Squamous Cell Carcinoma to Expand Treatment Pool
    NSCLC Therapeutics in Asia-Pacific Markets to 2019 Personalized Therapies Focus on Untapped Segment of Squamous Cell Carcinoma to Expand Treatment Pool GBI Research Report Guidance GBI Research Report Guidance Chapter two provides an overview of the disease, its symptoms, etiology, pathophysiology, diagnosis, classification, epidemiology, prognosis, staging and treatment options. Chapter three provides a detailed profiling and comparative heat map analysis in terms of safety and efficacy for currently marketed products in the NSCLC market. Chapter four presents a detailed pipeline analysis for the disease, including individual product profiles, a comparative efficacy and safety profile heat map analysis of the most promising pipeline products as well as analyses on the distribution of molecule types across the NSCLC developmental pipeline, the molecular targets of pipeline mAbs and the developmental program types. In addition, detailed analyses of the clinical trial failure rates, the clinical trial durations by phase and clinical trial sizes, by participant numbers. Chapter five provides market forecasts for countries across the globe, with special attention given to the APAC countries: India, Australia, China and Japan. The multiple scenario forecasts take into account a range of factors that are likely to vary and provide a clear perspective on the level of the potential degree of variance in the market sizes. Chapter six covers the major deals that have taken place in the disease market in recent years. Coverage includes co-development deals and licensing agreements, which are segmented on the basis of geography and total value. A concomitant analysis of the licensing deal values for products by molecule types and molecular targets is also provided.
    [Show full text]
  • Prostate Cancer
    NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Prostate Cancer Version 4.2019 — August 19, 2019 NCCN.org NCCN Guidelines for Patients® available at www.nccn.org/patients Continue Version 4.2019, 08/19/19 © 2019 National Comprehensive Cancer Network® (NCCN®), All rights reserved. NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN. NCCN Guidelines Index NCCN Guidelines Version 4.2019 Table of Contents Prostate Cancer Discussion *James L. Mohler, MD/Chair ω Celestia S. Higano, MD, FACP † ω Thomas J. Pugh, MD § Roswell Park Cancer Institute Fred Hutchinson Cancer Research Center/ University of Colorado Cancer Center Seattle Cancer Care Alliance Sandy Srinivas, MD/Vice Chair † Sylvia Richey, MD † Stanford Cancer Institute Eric Mark Horwitz, MD § St. Jude Children’s Research Hospital/The Fox Chase Cancer Center University of Tennessee Health Science Center Emmanuel S. Antonarakis, MD † The Sidney Kimmel Comprehensive Joseph E. Ippolito, MD, PhD ф Mack Roach, III, MD § Cancer Center at Johns Hopkins Siteman Cancer Center at Barnes- UCSF Helen Diller Family Jewish Hospital and Washington Comprehensive Cancer Center Andrew J. Armstrong, MD † University School of Medicine Duke Cancer Institute Stan Rosenfeld ¥ Christopher J. Kane, MD ω University of California San Francisco Anthony Victor D’Amico, MD, PhD § UC San Diego Moores Cancer Center Patient Services Committee Chair Dana-Farber/Brigham and Women’s Cancer Center | Massachusetts Michael R. Kuettel, MD, MBA, PhD § Edward Schaeffer, MD, PhDω General Hospital Cancer Center Roswell Park Cancer Institute Robert H. Lurie Comprehensive Cancer Center of Northwestern University Brian J. Davis, MD, PhD § Joshua M.
    [Show full text]
  • Comparator Report on Cancer in Europe 2019 −Disease Burden, Costs and Access to Medicines
    COMPARATOR REPORT ON CANCER IN EUROPE 2019 −DISEASE BURDEN, COSTS AND ACCESS TO MEDICINES THOMAS HOFMARCHER GUNNAR BRÅDVIK CHRISTER SVEDMAN PETER LINDGREN BENGT JÖNSSON IHE REPORT NILS WILKING 2019:7 COMPARATOR REPORT ON CANCER IN EUROPE 2019 – DISEASE BURDEN, COSTS AND ACCESS TO MEDICINES Thomas Hofmarcher Gunnar Brådvik Christer Svedman Peter Lindgren Bengt Jönsson Nils Wilking IHE - The Swedish Institute for Health Economics Updated version: October 2020 Please cite this report as: Hofmarcher, T., Brådvik, G., Svedman, C., Lindgren, P., Jönsson, B., Wilking, N. Comparator Report on Cancer in Europe 2019 – Disease Burden, Costs and Access to Medicines. IHE Report 2019:7. IHE: Lund, Sweden. This report was commissioned and funded by EFPIA - the European Federation of Pharmaceutical Industries and Associations and based on independent research delivered by IHE. EFPIA has had no influence or editorial control over the content of this report, and the views and opinions of the authors are not necessarily those of EFPIA. IHE REPORT 2019:7 e-ISSN: 1651-8187 ISSN: 1651-7628 The report can be downloaded from IHE’s website. www.ihe.se | [email protected] COMPARATOR REPORT ON CANCER IN EUROPE 2019 Foreword Cancer care remains one of the most intensely discussed health policy issues in Europe. Demographic factors such as an ageing population, in part driven by advancements in other medical fields, have led to an increased disease burden caused by cancer, both to patients and to the health care system as a whole. At the same time, there has been significant scientific advancements made, in some cases transforming cancer from a fatal to a chronic disease which in turn introduces new challenges that need to be addressed.
    [Show full text]
  • (FDA) Approved Bristol Myers Squibb's (Bms.Com) Br
    tools Approved Drugs (cemiplimab-rwlc) for patients with • On Dec. 18, 2020, the FDA approved locally advanced basal cell carcinoma Tagrisso® (osimertinib) (AstraZeneca, • On Feb. 5, 2021, the U.S. Food and Drug previously treated with a hedgehog astrazeneca.com) for adjuvant therapy Administration (FDA) approved Bristol pathway inhibitor (HHI) or for whom an after tumor resection in patients with ® Myers Squibb’s (bms.com) Breyanzi HHI is not appropriate and accelerated non-small cell lung cancer (NSCLC) whose (lisocabtagene maraleucel), a CD19- approval to Libtayo for patients with tumors have epidermal growth factor directed chimeric antigen receptor T-cell metastatic basal cell carcinoma previ- receptor exon 19 deletions or exon 21 therapy for the treatment of adult ously treated with an HHI or for whom an L858R mutations, as detected by an patients with relapsed or refractory large HHI is not appropriate. FDA-approved test. B-cell lymphoma after two or more lines • On Dec. 16, 2020, the FDA approved On Feb. 3, 2021, the FDA granted of systemic therapy, including diffuse ™ • Margenza (margetuximab-cmkb) ® large B-cell lymphoma not otherwise accelerated approval to Tepmetko (MacroGenics, macrogenics.com) in specified (including diffuse large B-cell (tepotinib) (EMD Serono, combination with chemotherapy for the lymphoma arising from indolent emdserono.com/us-en) for adult patients treatment of adult patients with with metastatic NSCLC harboring lymphoma), high-grade B-cell lymphoma, metastatic HER2-positive breast cancer primary mediastinal large B-cell mesenchymal-epithelial transition exon who have received two or more prior 14 skipping alterations. lymphoma, and follicular lymphoma anti-HER2 regimens, at least one of which grade 3B.
    [Show full text]
  • Prostate Cancer
    NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Prostate Cancer Version 4.2018 — August 15, 2018 NCCN.org NCCN Guidelines for Patients® available at www.nccn.org/patients Continue Version 4.2018, 08/15/18 © National Comprehensive Cancer Network, Inc. 2018, All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®. NCCN Guidelines Index NCCN Guidelines Version 4.2018 Table of Contents Prostate Cancer Discussion *James L. Mohler, MD/Chair ω Celestia S. Higano, MD † ω Sylvia Richey, MD † Roswell Park Cancer Institute Fred Hutchinson Cancer Research Center/ St. Jude Children’s Research Hospital/ Seattle Cancer Care Alliance University of Tennessee Health Science Center *Richard J. Lee, MD, PhD/Vice-Chair † Dana-Farber/Brigham and Women’s Cancer Eric Mark Horwitz, MD § Mack Roach, III, MD § Center | Massachusetts General Hospital Fox Chase Cancer Center UCSF Helen Diller Family Cancer Center Comprehensive Cancer Center Michael Hurwitz, MD, PhD † *Emmanuel S. Antonarakis, MD † Yale Cancer Center/Smilow Cancer Hospital Stan Rosenfeld ¥ The Sidney Kimmel Comprehensive University of California San Francisco Cancer Center at Johns Hopkins Joseph E. Ippolito, MD, PhD ф Patient Services Committee Chair Siteman Cancer Center at Barnes-Jewish *Andrew J. Armstrong, MD † Hospital and Washington University School of *Edward Schaeffer, MD, PhD ω Duke Cancer Institute Medicine Robert H. Lurie Comprehensive Cancer Center of Northwestern University Anthony Victor D’Amico, MD, PhD § Christopher J. Kane, MD ω Dana-Farber/Brigham and Women’s Cancer UC San Diego Moores Cancer Center Ahmad Shabsigh, MD ω Center | Massachusetts General Hospital The Ohio State University Comprehensive Cancer Center Michael Kuettel, MD, MBA, PhD § Cancer Center - James Cancer Hospital and Roswell Park Cancer Institute Solove Research Institute Brian J.
    [Show full text]
  • Recommendations from York and Scarborough Medicines
    Recommendations from York and Scarborough Medicines Commissioning Committee December 2018 Drug name Indication Recommendation, rationale and place in RAG status Potential full year cost impact therapy CCG commissioned Technology Appraisals 1. TA547: Tofacitinib for Tofacitinib is recommended, within its RED Estimate 15-20 patients a year across both moderately to severely active marketing authorisation, as an option for VoY & ScR CCGs. ulcerative colitis treating moderately to severely active ulcerative colitis in adults when conventional therapy or a Tofacitinib = £4900 pa per patient vs £8000- biological agent cannot be tolerated or the £9000 pa per patient for other biologics. disease has responded inadequately or lost No cost impact to CCGs expected. response to treatment. It is recommended only if the company provides tofacitinib with the discount agreed in the commercial arrangement. NHSE commissioned Technology Appraisals – for noting 2. TA545: Gemtuzumab Gemtuzumab ozogamicin, with daunorubicin RED No cost impact to CCGs as NHS England ozogamicin for untreated acute and cytarabine, is recommended as an option commissioned. myeloid leukaemia for untreated de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia, in people 15 years and over, only if: they start induction therapy when either the cytogenetic test confirms that the disease has favourable, intermediate or unknown cytogenetics (that is, because the test was unsuccessful) or when their cytogenetic test results are not yet available and they start consolidation therapy when their cytogenetic test confirms that the disease has favourable, intermediate or unknown cytogenetics (because the test was unsuccessful) and the company provides gemtuzumab ozogamicin according to the commercial arrangement. 3.
    [Show full text]
  • Insights Into Immunogenic Cell Death in Onco-Therapies
    cancers Review Restoring the Immunity in the Tumor Microenvironment: Insights into Immunogenic Cell Death in Onco-Therapies Ángela-Patricia Hernández 1 , Pablo Juanes-Velasco 1 , Alicia Landeira-Viñuela 1, Halin Bareke 1,2, Enrique Montalvillo 1, Rafael Góngora 1 and Manuel Fuentes 1,3,* 1 Department of Medicine and General Cytometry Service-Nucleus, CIBERONC CB16/12/00400, Cancer Research Centre (IBMCC/CSIC/USAL/IBSAL), 37007 Salamanca, Spain; [email protected] (Á.-P.H.); [email protected] (P.J.-V.); [email protected] (A.L.-V.); [email protected] (H.B.); [email protected] (E.M.); [email protected] (R.G.) 2 Department of Pharmaceutical Biotechnology, Faculty of Pharmacy, Institute of Health Sciences, Marmara University, 34722 Istanbul, Turkey 3 Proteomics Unit, Cancer Research Centre (IBMCC/CSIC/USAL/IBSAL), 37007 Salamanca, Spain * Correspondence: [email protected]; Tel.: +34-923-294-811 Simple Summary: Since the role of immune evasion was included as a hallmark in cancer, the idea of cancer as a single cell mass that replicate unlimitedly in isolation was dissolved. In this sense, cancer and tumorigenesis cannot be understood without taking into account the tumor microenvironment (TME) that plays a crucial role in drug resistance. Immune characteristics of TME can determine the success in treatment at the same time that antitumor therapies can reshape the immunity in TME. Here, we collect a variety of onco-therapies that have been demonstrated to induce an interesting Citation: Hernández, Á.-P.; immune response accompanying its pharmacological action that is named as “immunogenic cell Juanes-Velasco, P.; Landeira-Viñuela, death”. As this report shows, immunogenic cell death has been gaining importance in antitumor A.; Bareke, H.; Montalvillo, E.; therapy and should be studied in depth as well as taking into account other applications that may Góngora, R.; Fuentes, M.
    [Show full text]
  • CHMP Agenda of the 18-21 April 2017 Meeting
    18 April 2017 EMA/244895/2017 Inspections, Human Medicines Pharmacovigilance and Committees Division Committee for medicinal products for human use (CHMP) Draft agenda for the meeting on 18-21 April 2017 Chair: Tomas Salmonson – Vice-Chair: Harald Enzmann 18 April 2017, 12:30 – 21:00, room 3A 19 April 2017, 08:30 – 21:00, room 3A 20 April 2017, 08:30 – 21:00, room 3A 21 April 2017, 08:30 – 13:00, room 3A Health and safety information In accordance with the Agency’s health and safety policy, delegates are to be briefed on health, safety and emergency information and procedures prior to the start of the meeting. Disclaimers Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also vary during the course of the review. Additional details on some of these procedures will be published in the CHMP meeting highlights once the procedures are finalised and start of referrals will also be available. Of note, this agenda is a working document primarily designed for CHMP members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the agenda cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on- going procedures for which a final decision has not yet been adopted.
    [Show full text]
  • From January 2018
    Drug & Therapeutics Committee NICE Drug Technology Appraisals ratified by D&TC since 2018 These medicines have a positive NICE Technology Appraisal and are listed in the Trust Medicines Formulary when used in line with NICE recommendations and/or Local Trust Guidelines D&TC date NICE TA date Drug name Indication January 2018 November 2017 Aflibercept For treating choroidal neovascularisation (TA486) (recombinant fusion protein) January 2018 November 2017 Venetoclax For treating chronic (TA487) (selective inhibitor of B-cell lymphocytic leukaemia lymphoma-2 (BCL-2)) January 2018 November 2017 Regorafenib For previously treated (TA488) (inhibitor of several protein kinases) unresectable or metastatic gastrointestinal stromal tumours January 2018 November 2017 Vismodegib For treating of adult patients with: symptomatic metastatic basal (TA489) (hedgehog pathway inhibitor) cell carcinoma; locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy. January 2018 November 2017 Nivolumab For treating squamous cell carcinoma of the head and neck after (TA490) (human immunoglobulin G4 platinum-based chemotherapy monoclonal antibody) January 2018 November 2017 Ibrutinib For treating Waldenstrom’s macroglobulinaemia (TA491) (tyrosine kinase inhibitor) January 2018 December 2017 Atezolizumab For untreated locally (TA492) (monoclonal antibody, which binds advanced or metastatic urothelial cancer to the programmed death-1 (PD-1) when cisplatin is unsuitable receptor) January 2018 December 2017 Cladribine For treating (TA493) (antimetabolite) relapsing–remitting multiple sclerosis March 2018 December 2017 Naltrexone – bupropion Adjunct to a reduced-calorie diet and increased physical activity, for (TA 494) (Centrally acting appetite the management of weight in adult patients (aged 18 and over) suppressants) with an initial BMI of: 30 kg/m2 or more (obese) or from 27 kg/m2 to 30 kg/m2 (overweight) in the presence of one or more weight-related co-morbidities (such as type 2 diabetes, dyslipidaemia, or controlled hypertension).
    [Show full text]