Pipeline Summary

Total Page:16

File Type:pdf, Size:1020Kb

Pipeline Summary Pipeline summary Marketed products additional indications Global Development late-stage trials pRED (Roche Pharma Research & Early Development) gRED (Genentech Research & Early Development) Roche Group Q1 2018 results Diagnostics Foreign exchange rate information 48 Changes to the development pipeline Q1 2018 update New to phase I New to phase II New to phase III New to registration 2 NMEs: 1 NME: 2 AIs: 1 AI: RG6148 NME –HER2+ BC RG6268 entrectinib – NSCLC ROS1+ RG7446 Tecentriq + Avastin – 1L HCC RG105 MabThera/Rituxan – pemphigus RG6173 NME – asthma RG7446 Tecentriq – SCCHN adj vulgaris 1 AI: 1 NME from Chugai: RG6268 entrectinib – NTRK1 pan tumor CHU NME - endometriosis 3 AIs: RG7421 Cotellic + Tecentriq – RCC, UC, H&N cancer RG7440 ipatasertib + Tecentriq + taxane - TNBC RG7601 Venclexta + Cotellic ± Tecentriq - MM Removed from phase I Removed from phase II Removed from phase III Removed from registration 1 NME: 1 NME: 1 NME following EU approval: RG7945 NME - glaucoma RG3637 lebrikizumab ± Esbriet – IPF RG6013 Hemlibra – hemophilia A FVIII inh 1 AI following US approval: RG3645 Lucentis 0.3mg PFS – DME/DR 49 Status as of April 26, 2018 Roche Group development pipeline Phase I (45 NMEs + 26 AIs) RG6264 Perjeta + Herceptin FDC SC HER2+ BC T + Cotellic solid tumors RG6069 anti-fibrotic agent fibrosis RG6026 CD20 TCB heme tumors T + ipi/IFN solid tumors RG6107 C5 inh MAb PNH RG6058 tiragolumab (TIGIT) ± T solid tumors T + Tarceva/Alecensa NSCLC RG6151 - asthma RG6109 - AML T + anti-CD20 combos heme tumors RG6173 - asthma RG6114 mPI3K alpha inh HR+ BC T ± lenalidomide ± daratumumab MM RG6174 - inflammatory diseases RG6146 BET inh combos solid + heme tumors RG7446 T + K/HP HER2+ BC RG7835 IgG-IL2 FP autoimmune diseases RG6148 - HER2+ BC T + HMA MDS RG7880 IL-22Fc inflammatory diseases RG6160 - multiple myeloma T + radium 223 mCRPC RG7990 - asthma RG6171 SERD (3) ER+ (HER2neg) mBC T + guadecitabine AML RG6004 HBV LNA HBV RG6180 personalized cancer vaccine ± T oncology T + rucaparib ovarian ca RG6080 nacubactam bact. infections RG6185 pan-RAF inh + Cotellic solid tumors T + Gazyva/tazemetostat r/r DLBCL + FL RG7854 TLR7 agonist (3) HBV emactuzumab + T solid tumors RG7461 FAP IL2v FP combos solid tumors RG7861 anti-S. aureus TAC infectious diseases RG7155 emactuzumab + selicrelumab solid tumors Venclexta + Cotellic/idasanutlin AML RG7907 HBV Capsid (2) HBV RG7159 anti-CD20 combos heme tumors RG7601 Venclexta ± azacitadine r/r MDS RG7992 FGFR1/KLB MAb metabolic diseases RG7386 FAP-DR5 biMAb solid tumors Venclexta + Cotellic ± T MM RG6000 - ALS Cotellic + Zelboraf + T melanoma RG7741 ChK1 inh solid tumors RG6029 Nav1.7 inh (2) pain RG7421 Cotellic + T 2L BRAF WT mM RG7802 CEA TCB ± T solid tumors RG6042 ASO Huntington’s Cotellic + T RCC, UC, H&N ca RG7813 CEA IL2v FP* + T solid tumors RG7816 GABA Aa5 PAM autism RG7440 ipatasertib + taxane + T TNBC RG7828 CD20 TDB ± T heme tumors RG7906 - psychiatric disorders Tecentriq solid tumors selicrelumab (CD40) + T solid tumors RG6147 - geographic atrophy RG7876 Tecentriq NMIBC selicrelumab + vanucizumab solid tumors PTH1 recep. ago hypoparathyroidism RG7446 T-based Morpheus platform solid tumors RG7882 MUC16 ADC ovarian ca CHU - hyperphosphatemia T + Avastin + Cotellic 2/3L CRC Raf/MEK dual inh solid tumors - endometriosis CHU T ± Avastin ± chemo HCC, GC, PaC glypican-3/CD3 biMAb solid tumors New Molecular Entity (NME) CardioMetabolism RG-No Roche/Genentech *INN: cergutuzumab amunaleukin Additional Indication (AI) Neuroscience CHU Chugai managed **out-licensed to Galderma and Maruho AD Oncology Ophthalmology PRO Proximagen managed *** Ph2 pivotal Immunology Other NOV Novimmune managed T=Tecentriq Infectious Diseases RG1569 Branded as RoActemra (EU) TCB=T cell bispecific TDB=T cell dependent bispecific 50 Status as of April 26, 2018 Roche Group development pipeline Phase II (19 NMEs + 10 AIs) Phase III (9 NMEs + 36 AIs) entrectinib NSCLC ROS1+ Kadcyla HER2+ BC adj RG7446/RG7853 Tecentriq or Alecensa 1L NSCLC Dx+ RG6268 RG3502 entrectinib NTRK1 pan tumor Kadcyla + Perjeta HER2+ BC adj Venclexta + Gazyva 1L CLL RG7388 idasanutlin polycythemia vera Hemlibra hemophilia A w/o FVIII inh Venclexta + bortezomib MM RG6013 RG7601 RG7421 Cotellic + T ± taxane TNBC Hemlibra Q4W hemophilia A Venclexta + azacitidine 1L AML RG7440 ipatasertib TNBC neoadj RG7388 idasanutlin + chemo AML Venclexta + LDAC 1L AML RG7596 polatuzumab vedotin r/r DLBCL + FL ipatasertib + abiratorone 1L CRPC RG7604 taselisib + fulvestrant ER+(HER2-neg) mBC Venclexta + Rituxan DLBCL RG7440 ipatasertib + chemo 1L TNBC/HR+ BC RG7601 Venclexta + Rituxan r/r FL RG105 MabThera pemphigus vulgaris Cotellic+Zelboraf+T 1L BRAFm melanoma RG1569 Actemra systemic sclerosis Venclexta + azacitadine 1L MDS RG7421 RG7604 taselisib + letrozole (HER2-neg) BC neoadj Cotellic + T 1L BRAF WT melanoma RG3648 Xolair nasal polyps RG7686 codrituzumab HCC RG7596 polatuzumab vedotin 1L DLBCL etrolizumab ulcerative colitis RG7413 RG6125 Cadherin-11 MAb RA Tecentriq NSCLC adj etrolizumab Crohn’s RG6149 ST2 MAb asthma Tecentriq MIBC adj RG6152 baloxavir marboxil influenza RG7159 obinutuzumab lupus Tecentriq Dx+ 1L sq + non-sq SCLC RG1450 gantenerumab Alzheimer’s RG7625 Cat-S antag autoimmune diseases Tecentriq RCC adj RG6168 satralizumab NMO RG7845 fenebrutinib (BTK inh) RA, lupus, CSU T + nab-paclitaxel 1L non-sq NSCLC RG6206 anti-myostatin adnectin DMD CHU nemolizumab** pruritus in dialysis patients T + chemo+ Avastin 1L ovarian cancer RG7412 crenezumab Alzheimer’s PRO VAP-1 inh inflammatory disease T + chemo + Avastin 1L non-sq NSCLC NOV TLR4 MAb autoimmune diseases T + pemetrexed 1L non-sq NSCLC CHU URAT1 inh gout T + nab-paclitaxel 1L sq NSCLC Registration (5 AIs) RG1662 basmisanil CIAS RG7446 T ± chemo SCCHN adj RG435 Avastin1 ovarian FL RG1678 bitopertin beta thalassemia T + paclitaxel 1L TNBC RG1273 Perjeta + Herceptin2 HER2+ BC adj RG6083 olesoxime SMA T + nab-paclitaxel 1L TNBC RG7601 Venclexta + Rituxan r/r CLL RG6100 Tau MAb Alzheimer’s T + nab-paclitaxel TNBC neoadj RG1569 Actemra auto injector3 RA RG7314 balovaptan autism T + Avastin RCC RG105 MabThera/Rituxan pemphigus vulgaris RG7916 SMN2 splicer(2)*** SMA T + Avastin 1L HCC 1 2 3 RG7935 α-synuclein MAb Parkinson's T + Cotellic 3L CRC US only, Approved in US, Approved in EU RG3645 ranibizumab PDS wAMD See previous page for legend T ± chemo 1L mUC RG7716 VEGF-ANG2 biMAb wAMD, DME T + chemo 1L extensive stage SCLC T + enzalutamide CRPC 51 Status as of April 26, 2018 NME submissions and their additional indications Projects currently in phase II and III New Molecular Entity (NME) CardioMetabolism Additional Indication (AI) Neuroscience Oncology Ophthalmology Immunology Other Infectious Diseases ✓ Indicates submission to health authorities has occurred Unless stated otherwise submissions are planned to occur in US and EU gantenerumab RG1450 Alzheimer‘s basmisanil VEGF/ANG2 biMAb RG1662 RG7716 CIAS wAMD/DME bitopertin Cadherin-11 MAb RG1678 RG6125 beta thalassemia RA anti-myostatin adnectin olesoxime ST2 MAb RG6206 RG6083 RG6149 DMD SMA asthma satralizumab SMN2 splicer(2) idasanutlin Tau MAb etrolizumab RG6168 (SA237) RG7916 RG7388 RG6100 RG7413 SMA polycythemia vera Alzheimer’s neuromyelitis optica ulcerative colitis baloxavir marboxil entrectinib ipatasertib+abiratorone ipatasertib balovaptan etrolizumab RG6152 RG6268 RG7440 RG7440 RG7314 RG7413 Influenza NSCLC ROS1+ 1L CRPC TNBC neoadj autism Crohn’s polatuzumab vedotin entrectinib polatuzumab vedotin polatuzumab vedotin crenezumab Cat S antag RG7596 RG6268 RG7596 RG7596 RG7412 RG7625 r/r DLBCL NTRK1 pantumor r/r FL 1L DLBCL Alzheimer’s autoimmune diseases taselisib+fulvestrant taselisib + letrozole idasanutlin ipatasertib +chemo α-synuclein MAb fenebrutinib RG7604 PIK3CAmut ER+ RG7388 RG7440 RG7604 ER+ (HER2-neg) RG7935 RG7845 Parkinson’s autoimmune diseases (HER2-neg) mBC AML 1L TNBC / HR+ BC BC neoadj 2018 2019 2020 2021 and beyond Status as of April 26, 2018 52 AI submissions for existing products; currently in phase II and III MabThera ✓ RG105 pemphigus vulgaris New Molecular Entity (NME) CardioMetabolism Actemra RG1569 Additional Indication (AI) Neuroscience systemic sclerosis Oncology Ophthalmology Actemra auto injector (US) RG1569 Immunology Other RA/GCA ✓ Infectious Diseases Hemlibra RG6013 hemophilia A FVIII non-inh ✓ Indicates submission to health authorities has occurred Unless stated otherwise submissions are planned to occur in US and EU Hemlibra RG6013 hemophilia A, Q4W Venclexta + Rituxan (EU) ✓ RG7601 r/r CLL Venclexta + aza/LDAC RG7601 1L AML Tecentriq + Cotellic ranibizumab PDS RG7446 RG3645 3L CRC wAMD Cotellic + Tecentriq Tecentriq+chemo+Avastin RG7421 obinutuzumab RG7446 1L BRAF WT melanoma RG7159 1L non-sq NSCLC lupus nephritis Cotellic + Tecentriq + Tecentriq + nab-paclitaxel Xolair RG7446/ Tecentriq or Alecensa RG7446 RG7421 Zelboraf RG3648 1L sq NSCLC 1L BRAFmut melanoma nasal polyps RG7853 1L NSCLC Dx+ Tecentriq + nab-paclitaxel Tecentriq Kadcyla Tecentriq RG7446 RG7446 RG3502 RG7446 1L non-sq NSCLC 1L non-sq + sq NSCLC (Dx+) HER2+ BC adj. NSCLC adj Tecentriq + pemetrexed Tecentriq + nab-paclitaxel Kadcyla + Perjeta Venclexta + Rituxan Tecentriq RG7446 RG7446 RG3502 RG7601 RG7446 1L non-sq NSCLC TNBC neoadj HER2+ BC adj. r/r FL MIBC adj Tecentriq + chemo Tecentriq + paclitaxel Tecentriq ± chemo Venclexta + Rituxan Tecentriq RG7446 RG7446 RG7446 RG7601 RG7446 1L extens. stage SCLC 1L TNBC 1L mUC DLBCL RCC adj Tecentriq + Avastin Venclexta + Gazyva Tecentriq + enzalutamide Venclexta + aza Tecentriq + Avastin RG7446
Recommended publications
  • Polatuzumab Vedotin - R/R DLBCL RG7769 PD1-TIM3 Bimab - Solid Tumors NSCLC RG7446 Tecentriq – Her2-Pos
    Pipeline summary Marketed products additional indications Global Development late-stage trials pRED (Roche Pharma Research & Early Development) gRED (Genentech Research & Early Development) 1 Changes to the development pipeline FY 2018 update New to phase I New to phase II New to phase III New to registration 3 NMEs: 2 NMEs transitioned from Ph1 1 NME transitioned from Ph2: 2 NMEs + 1 AI transitioned from Ph2 RG6217 - HBV RG7906 - psychiatric disorders RG6042 HTT ASO - Huntington’s following filing in EU and US: RG6237 - neuromuscular disorders RG6058 tiragolumab + Tecentriq - 6 AIs: RG7596 polatuzumab vedotin - r/r DLBCL RG7769 PD1-TIM3 biMAb - solid tumors NSCLC RG7446 Tecentriq – Her2-pos. BC neoadj RG6268 entrectinib - NSCLC ROS1+ 1 AI: 1 NME starting Ph2 RG7446 Tecentriq – high risk NMIBC RG6268 entrectinib – NTRK1 pan-tumor RG7601 Venclexta + gilteritinib – r/r RG6180 iNeST (personalized cancer RG6152 Xofluza - influenza hosp. patients 3 AIs transitioned from Ph3 following AML vaccine) + pembrolizumab - malignant RG6152 Xofluza – influenza pediatric filing in EU and US: melanoma patients RG7446 Tecentriq + nab-paclitaxel 1L 1 NME following termination of Ph3 RG7601 Venclexta - r/r MM t(11:14) non sq NSCLC RG7412 crenezumab – familial RG7601 Venclexta + HMA/LDAC - 1L RG7446 Tecentriq + nab-paclitaxel Alzheimer’s disease healthy individuals AML* 1LTNBC RG7446 Tecentriq + chemo - 1L extensive 1 AI: stage SCLC RG7446 Tecentriq SC – NSCLC Removed from phase I Removed from phase II Removed from phase III Removed from registration 2 NMEs:
    [Show full text]
  • Predictive QSAR Tools to Aid in Early Process Development of Monoclonal Antibodies
    Predictive QSAR tools to aid in early process development of monoclonal antibodies John Micael Andreas Karlberg Published work submitted to Newcastle University for the degree of Doctor of Philosophy in the School of Engineering November 2019 Abstract Monoclonal antibodies (mAbs) have become one of the fastest growing markets for diagnostic and therapeutic treatments over the last 30 years with a global sales revenue around $89 billion reported in 2017. A popular framework widely used in pharmaceutical industries for designing manufacturing processes for mAbs is Quality by Design (QbD) due to providing a structured and systematic approach in investigation and screening process parameters that might influence the product quality. However, due to the large number of product quality attributes (CQAs) and process parameters that exist in an mAb process platform, extensive investigation is needed to characterise their impact on the product quality which makes the process development costly and time consuming. There is thus an urgent need for methods and tools that can be used for early risk-based selection of critical product properties and process factors to reduce the number of potential factors that have to be investigated, thereby aiding in speeding up the process development and reduce costs. In this study, a framework for predictive model development based on Quantitative Structure- Activity Relationship (QSAR) modelling was developed to link structural features and properties of mAbs to Hydrophobic Interaction Chromatography (HIC) retention times and expressed mAb yield from HEK cells. Model development was based on a structured approach for incremental model refinement and evaluation that aided in increasing model performance until becoming acceptable in accordance to the OECD guidelines for QSAR models.
    [Show full text]
  • Classification Decisions Taken by the Harmonized System Committee from the 47Th to 60Th Sessions (2011
    CLASSIFICATION DECISIONS TAKEN BY THE HARMONIZED SYSTEM COMMITTEE FROM THE 47TH TO 60TH SESSIONS (2011 - 2018) WORLD CUSTOMS ORGANIZATION Rue du Marché 30 B-1210 Brussels Belgium November 2011 Copyright © 2011 World Customs Organization. All rights reserved. Requests and inquiries concerning translation, reproduction and adaptation rights should be addressed to [email protected]. D/2011/0448/25 The following list contains the classification decisions (other than those subject to a reservation) taken by the Harmonized System Committee ( 47th Session – March 2011) on specific products, together with their related Harmonized System code numbers and, in certain cases, the classification rationale. Advice Parties seeking to import or export merchandise covered by a decision are advised to verify the implementation of the decision by the importing or exporting country, as the case may be. HS codes Classification No Product description Classification considered rationale 1. Preparation, in the form of a powder, consisting of 92 % sugar, 6 % 2106.90 GRIs 1 and 6 black currant powder, anticaking agent, citric acid and black currant flavouring, put up for retail sale in 32-gram sachets, intended to be consumed as a beverage after mixing with hot water. 2. Vanutide cridificar (INN List 100). 3002.20 3. Certain INN products. Chapters 28, 29 (See “INN List 101” at the end of this publication.) and 30 4. Certain INN products. Chapters 13, 29 (See “INN List 102” at the end of this publication.) and 30 5. Certain INN products. Chapters 28, 29, (See “INN List 103” at the end of this publication.) 30, 35 and 39 6. Re-classification of INN products.
    [Show full text]
  • WO 2016/176089 Al 3 November 2016 (03.11.2016) P O P C T
    (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 2016/176089 Al 3 November 2016 (03.11.2016) P O P C T (51) International Patent Classification: BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, A01N 43/00 (2006.01) A61K 31/33 (2006.01) DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, (21) International Application Number: KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, PCT/US2016/028383 MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, (22) International Filing Date: PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, 20 April 2016 (20.04.2016) SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (25) Filing Language: English (84) Designated States (unless otherwise indicated, for every (26) Publication Language: English kind of regional protection available): ARIPO (BW, GH, (30) Priority Data: GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, 62/154,426 29 April 2015 (29.04.2015) US TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, (71) Applicant: KARDIATONOS, INC. [US/US]; 4909 DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, Lapeer Road, Metamora, Michigan 48455 (US).
    [Show full text]
  • University of Groningen PET Imaging and in Silico Analyses to Support
    University of Groningen PET imaging and in silico analyses to support personalized treatment in oncology Moek, Kirsten DOI: 10.33612/diss.112978295 IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite from it. Please check the document version below. Document Version Publisher's PDF, also known as Version of record Publication date: 2020 Link to publication in University of Groningen/UMCG research database Citation for published version (APA): Moek, K. (2020). PET imaging and in silico analyses to support personalized treatment in oncology. Rijksuniversiteit Groningen. https://doi.org/10.33612/diss.112978295 Copyright Other than for strictly personal use, it is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), unless the work is under an open content license (like Creative Commons). The publication may also be distributed here under the terms of Article 25fa of the Dutch Copyright Act, indicated by the “Taverne” license. More information can be found on the University of Groningen website: https://www.rug.nl/library/open-access/self-archiving-pure/taverne- amendment. Take-down policy If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim. Downloaded from the University of Groningen/UMCG research database (Pure): http://www.rug.nl/research/portal. For technical reasons the number of authors shown on this cover page is limited to 10 maximum. Download date: 30-09-2021 06 The antibody-drug conjugate target landscape across a broad range of tumor types Kirsten L.
    [Show full text]
  • Ep 3178848 A1
    (19) TZZ¥__T (11) EP 3 178 848 A1 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: (51) Int Cl.: 14.06.2017 Bulletin 2017/24 C07K 16/28 (2006.01) A61K 39/395 (2006.01) C07K 16/30 (2006.01) (21) Application number: 15198715.3 (22) Date of filing: 09.12.2015 (84) Designated Contracting States: (72) Inventor: The designation of the inventor has not AL AT BE BG CH CY CZ DE DK EE ES FI FR GB yet been filed GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR (74) Representative: Cueni, Leah Noëmi et al Designated Extension States: F. Hoffmann-La Roche AG BA ME Patent Department Designated Validation States: Grenzacherstrasse 124 MA MD 4070 Basel (CH) (71) Applicant: F. Hoffmann-La Roche AG 4070 Basel (CH) (54) TYPE II ANTI-CD20 ANTIBODY FOR REDUCING FORMATION OF ANTI-DRUG ANTIBODIES (57) The present invention relates to methods of treating a disease, and methods for reduction of the formation of anti-drug antibodies (ADAs) in response to the administration of a therapeutic agent comprising administration of a Type II anti-CD20 antibody, e.g. obinutuzumab, to the subject prior to administration of the therapeutic agent. EP 3 178 848 A1 Printed by Jouve, 75001 PARIS (FR) EP 3 178 848 A1 Description Field of the Invention 5 [0001] The present invention relates to methods of treating a disease, and methods for reduction of the formation of anti-drug antibodies (ADAs) in response to the administration of a therapeutic agent.
    [Show full text]
  • (INN) for Biological and Biotechnological Substances
    INN Working Document 05.179 Update 2013 International Nonproprietary Names (INN) for biological and biotechnological substances (a review) INN Working Document 05.179 Distr.: GENERAL ENGLISH ONLY 2013 International Nonproprietary Names (INN) for biological and biotechnological substances (a review) International Nonproprietary Names (INN) Programme Technologies Standards and Norms (TSN) Regulation of Medicines and other Health Technologies (RHT) Essential Medicines and Health Products (EMP) International Nonproprietary Names (INN) for biological and biotechnological substances (a review) © World Health Organization 2013 All rights reserved. Publications of the World Health Organization are available on the WHO web site (www.who.int ) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected] ). Requests for permission to reproduce or translate WHO publications – whether for sale or for non-commercial distribution – should be addressed to WHO Press through the WHO web site (http://www.who.int/about/licensing/copyright_form/en/index.html ). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned.
    [Show full text]
  • 761121Orig1s000
    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 761121Orig1s000 CLINICAL REVIEW(S) CLINICAL REVIEW Application Type Original BLA Application Number 761121 Priority or Standard Priority Submit Dates 11/21/2018, 12/19/2018 Received Dates 11/21/2018, 12/19/2018 PDUFA Goal Date 8/19/2019 Division/Office DHP / OHOP Reviewer Names Yvette Kasamon, M.D. (primary clinical reviewer) R. Angelo de Claro, M.D. (team leader) Review Completion Date 5/28/2019 Established/Proper Name Polatuzumab vedotin-piiq (DCDS4501A) (Proposed) Trade Name Polivy Applicant Genentech, Inc. Dosage Form For injection: 140 mg of polatuzumab vedotin-piiq as a lyophilized powder in a single-dose vial Applicant Proposed 1.8 mg/kg IV infusion every 21 days for 6 cycles, in combination with Dosing Regimen bendamustine (90 mg/m2/day for 2 days) and rituximab (b) (4) Applicant Proposed Indication/Population Recommendation on Accelerated approval Regulatory Action Recommended In combination with bendamustine and a rituximab product for the Indication/Population treatment of adult patients with relapsed or refractory diffuse large B- cell lymphoma, not otherwise specified, after at least two prior therapies Reference ID: 44400814446194 BLA 761121 Clinical Review Yvette Kasamon, MD Polivy (polatuzumab vedotin-piiq) Table of Contents Glossary ........................................................................................................................................... 6 1. Executive Summary ................................................................................................................
    [Show full text]
  • Polatuzumab Vedotin -1L DLBCL RG7601 Venclexta + LDAC – 1L AML
    Pipeline summary Marketed products additional indications Global Development late-stage trials pRED (Roche Pharma Research & Early Development) gRED (Genentech Research & Early Development) 1 Changes to the development pipeline FY 2017 update New to phase I New to phase II New to phase III New to registration 6 NMEs: 1 NME: 1 NMEs: 1 AI following filing in US and EU: RG6109 NME - AML RG1678 bitopertin – beta thalassemia RG6152 baloxavir marboxil (CAP RG7601 Venclexta + Rituxan – r/r CLL RG6151 NME - asthma endonuclease inh) – influenza RG6171 SERD (3) – ER+ (HER2neg) mBC 2 AIs following filing in US: RG6174 NME – inflammatory diseases 6 AIs: RG435 Avastin – FL ovarian cancer RG6264 Perjeta + Herceptin FDC SC – RG3648 Xolair – nasal polyps RG3645 Lucentis 0.3mg PFS – DME/DR HER2+ eBC RG7421 Cotellic + Tecentriq – 1L BRAF WT RG7816 GABA-Aa5 PAM - autism melanoma 1 AI following filing in EU: RG7440 ipatasertib – 1L TNBC/HR+ BC RG1569 Actemra auto injector – RA 1 AIs: RG7446/RG7853 Tecentriq or Alecensa - 1L RG7446 Tecentriq + tazemetostat – r/r NSCLC Dx+ DLBCL RG7596 polatuzumab vedotin -1L DLBCL RG7601 Venclexta + LDAC – 1L AML Removed from phase I Removed from phase II Removed from phase III Removed from registration 3 NMEs: 1 AI: 1 NME: 3 AIs following US approval: RG6047 SERD (2) – ER+ (HER-neg) mBC RG3502 Kadcyla + Tecentriq – 2L Her2+ RG7417 lampalizumab – geographic atrophy RG435 Avastin - GBM RG7203 PDE10A inh – schizophrenia mBC RG7159 Gazyva – 1L FL RG7986 ADC – r/r NHL RG7204 Zelboraf – Erdheim-Chester disease 1 AI following US
    [Show full text]
  • NSCLC (Update) • Cotellic + Zelboraf: Phase III 1L Melanoma (Cobrim), Overall Survival
    Roche YTD September 2015 sales Basel, 22 October 2015 This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this presentation, among others: 1 pricing and product initiatives of competitors; 2 legislative and regulatory developments and economic conditions; 3 delay or inability in obtaining regulatory approvals or bringing products to market; 4 fluctuations in currency exchange rates and general financial market conditions; 5 uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side-effects of pipeline or marketed products; 6 increased government pricing pressures; 7 interruptions in production; 8 loss of or inability to obtain adequate protection for intellectual property rights; 9 litigation; 10 loss of key executives or other employees; and 11 adverse publicity and news coverage. Any statements regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this year or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche. For marketed products discussed in this presentation, please see full prescribing information on our website www.roche.com All mentioned trademarks are legally protected.
    [Show full text]
  • IMSN Letter on Antibody-Drug Conjugates 2015 03 23
    March 23, 2015 Dr Raffaella G. Balocco Mattavelli Manager of the International Nonproprietary Name (INN) Programme Quality Assurance and Safety: Medicines Department of Essential Medicines and Health Products (EMP) World Health Organization CH 1211 GENEVA 27 - SWITZERLAND Dear Dr Mattavelli: This letter is in regards to nomenclature of antibody-drug conjugates • As you are aware, during the clinical trials of trastuzumab emtansine, deaths resulting from confusion with trastuzumab drew attention to the risks associated with International nonproprietary names (INNs) of such cytotoxic substances with a common part. • The International Medication Safety Network (IMSN) was quickly alerted to these risks, and proposed that a new substitute INN should be examined by the WHO INN Programme, the only international body in charge eventually changing an INN. A proposal for substitution of trastuzumab emtansine is expected to be submitted by Canadian Healthcare authorities according to the international procedure. • By studying the possibilities of preventing this type of error, the IMSN found that these risks of confusion apply to all antibody-drug conjugates. The IMSN is therefore calling on the WHO INN Programme to identify nomenclature that will reduce their potentially fatal similarities and define clear rules to help recognize products that include different substances, in order to make them safer. If necessary, the IMSN is ready to contribute to the assessment of this risk reduction and prevention strategy, essential but belonging to the sole authority of the WHO INN Programme. The trastuzumab emtansine case. In 2013 the confusion between trastuzumab and trastuzumab emtansine drew attention to the risks associated with the INNs of cytotoxic compounds with a common part.
    [Show full text]
  • Stembook 2018.Pdf
    The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances FORMER DOCUMENT NUMBER: WHO/PHARM S/NOM 15 WHO/EMP/RHT/TSN/2018.1 © World Health Organization 2018 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances. Geneva: World Health Organization; 2018 (WHO/EMP/RHT/TSN/2018.1). Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data.
    [Show full text]