NICE TA Adherence Checklist 2020/2021 ELHE
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WO 2018/223101 Al 06 December 2018 (06.12.2018) 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 2018/223101 Al 06 December 2018 (06.12.2018) W !P O PCT (51) International Patent Classification: (71) Applicant: JUNO THERAPEUTICS, INC. [US/US]; 400 A 61K 35/1 7 (20 15.0 1) A 61P 35/00 (2006 .0 1) Dexter Ave. N., Suite 1200, Seattle, WA 98109 (US). (21) International Application Number: (72) Inventor: ALBERTSON, Tina; 400 Dexter Ave. N., Suite PCT/US2018/035755 1200, Seattle, WA 98109 (US). (22) International Filing Date: (74) Agent: AHN, Sejin et al; Morrison & Foerster LLP, 1253 1 0 1 June 2018 (01 .06.2018) High Bluff Drive, Suite 100, San Diego, CA 92130-2040 (US). (25) Filing Language: English (81) Designated States (unless otherwise indicated, for every (26) Publication Language: English kind of national protection available): AE, AG, AL, AM, (30) Priority Data: AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, 62/5 14,774 02 June 2017 (02.06.2017) US CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, 62/5 15,530 05 June 2017 (05.06.2017) US DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, 62/521,366 16 June 2017 (16.06.2017) u s HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, 62/527,000 29 June 2017 (29.06.2017) u s KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, 62/549,938 24 August 2017 (24.08.2017) u s MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, 62/580,425 0 1 November 2017 (01 .11.2017) u s OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, 62/593,871 0 1 December 2017 (01 .12.2017) u s SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, 62/596,764 08 December 2017 (08.12.2017) u s TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. -
JAK-Inhibitors for the Treatment of Rheumatoid Arthritis: a Focus on the Present and an Outlook on the Future
biomolecules Review JAK-Inhibitors for the Treatment of Rheumatoid Arthritis: A Focus on the Present and an Outlook on the Future 1, 2, , 3 1,4 Jacopo Angelini y , Rossella Talotta * y , Rossana Roncato , Giulia Fornasier , Giorgia Barbiero 1, Lisa Dal Cin 1, Serena Brancati 1 and Francesco Scaglione 5 1 Postgraduate School of Clinical Pharmacology and Toxicology, University of Milan, 20133 Milan, Italy; [email protected] (J.A.); [email protected] (G.F.); [email protected] (G.B.); [email protected] (L.D.C.); [email protected] (S.B.) 2 Department of Clinical and Experimental Medicine, Rheumatology Unit, AOU “Gaetano Martino”, University of Messina, 98100 Messina, Italy 3 Experimental and Clinical Pharmacology Unit, Centro di Riferimento Oncologico di Aviano (CRO), Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Pordenone, 33081 Aviano, Italy; [email protected] 4 Pharmacy Unit, IRCCS-Burlo Garofolo di Trieste, 34137 Trieste, Italy 5 Head of Clinical Pharmacology and Toxicology Unit, Grande Ospedale Metropolitano Niguarda, Department of Oncology and Onco-Hematology, Director of Postgraduate School of Clinical Pharmacology and Toxicology, University of Milan, 20162 Milan, Italy; [email protected] * Correspondence: [email protected]; Tel.: +39-090-2111; Fax: +39-090-293-5162 Co-first authors. y Received: 16 May 2020; Accepted: 1 July 2020; Published: 5 July 2020 Abstract: Janus kinase inhibitors (JAKi) belong to a new class of oral targeted disease-modifying drugs which have recently revolutionized the therapeutic panorama of rheumatoid arthritis (RA) and other immune-mediated diseases, placing alongside or even replacing conventional and biological drugs. -
Comparative Efficacy and Safety of Lorlatinib and Alectinib for ALK
cancers Systematic Review Comparative Efficacy and Safety of Lorlatinib and Alectinib for ALK-Rearrangement Positive Advanced Non-Small Cell Lung Cancer in Asian and Non-Asian Patients: A Systematic Review and Network Meta-Analysis Koichi Ando 1,2,* , Ryo Manabe 1, Yasunari Kishino 1, Sojiro Kusumoto 1, Toshimitsu Yamaoka 3 , Akihiko Tanaka 1, Tohru Ohmori 1,4 and Hironori Sagara 1 1 Division of Respiratory Medicine and Allergology, Department of Medicine, Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan; [email protected] (R.M.); [email protected] (Y.K.); [email protected] (S.K.); [email protected] (A.T.); [email protected] (T.O.); [email protected] (H.S.) 2 Division of Internal Medicine, Showa University Dental Hospital Medical Clinic, Senzoku Campus, Showa University, 2-1-1 Kita-senzoku, Ohta-ku, Tokyo 145-8515, Japan 3 Advanced Cancer Translational Research Institute, Showa University, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, Japan; [email protected] 4 Department of Medicine, Division of Respiratory Medicine, Tokyo Metropolitan Health and Hospitals Corporation, Ebara Hospital, 4-5-10 Higashiyukigaya, Ohta-ku, Tokyo 145-0065, Japan * Correspondence: [email protected]; Tel.: +81-3-3784-8532 Citation: Ando, K.; Manabe, R.; Kishino, Y.; Kusumoto, S.; Yamaoka, Simple Summary: The treatment of anaplastic lymphoma kinase (ALK) rearrangement-positive T.; Tanaka, A.; Ohmori, T.; Sagara, H. (ALK-p) advanced non-small cell lung cancer (NSCLC) remains a challenge. -
Study Protocol
(rJ GI LEAi) Galapagos CLINICAL STUDY PROTOCOL Study Title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn’s Disease (SBCD) Sponsor: Gilead Sciences, Inc. 333 Lakeside Drive Foster City, CA 94404, USA IND Number: 129646 EudraCT Number: 2016-003179-23 Clinical Trials.gov NCT03046056 Identifier: Indication: Small Bowel Crohn’s Disease Protocol ID: GS-US-419-4015 Contact Information: The medical monitor name and contact information will be provided on the Key Study Team Contact List. Protocol Original: 12 September 2016 Version/Date: Amendment 1: 16 December 2016 Amendment 2: 26 June 2017 Amendment 3: 04 February 2020 CONFIDENTIALITY STATEMENT The information contained in this document, particularly unpublished data, is the property or under control of Gilead Sciences, Inc., and is provided to you in confidence as an investigator, potential investigator, or consultant, for review by you, your staff, and an applicable Institutional Review Board or Independent Ethics Committee. The information is only to be used by you in connection with authorized clinical studies of the investigational drug described in the protocol. You will not disclose any of the information to others without written authorization from Gilead Sciences, Inc., except to the extent necessary to obtain informed consent from those persons to whom the drug may be administered. Filgotinib Protocol GS-US-419-4015 Final Gilead Sciences, lnc. Amendment3 TABLE OF CONTENTS TABLE -
Recommendations from York and Scarborough Medicines
Recommendations from York and Scarborough Medicines Commissioning Committee March 2021 Drug name Indication Recommendation, rationale and place in RAG status Potential full year cost impact therapy CCG commissioned Technology Appraisals 1. TA672: Brolucizumab for Brolucizumab is recommended as an option for treating wet Listed as RED Discussed and approved at Feb 2021 MCC meeting. treating wet age-related age-related macular degeneration in adults, only if, in the eye drug macular degeneration to be treated: the best-corrected visual acuity is between 6/12 and Commissioning: CCG, 6/96 tariff excluded there is no permanent structural damage to the central fovea the lesion size is less than or equal to 12 disc areas in greatest linear dimension and there is recent presumed disease progression (for example, blood vessel growth, as shown by fluorescein angiography, or recent visual acuity changes). It is recommended only if the company provides brolucizumab according to the commercial arrangement. If patients and their clinicians consider brolucizumab to be one of a range of suitable treatments, including aflibercept and ranibizumab, choose the least expensive (taking into account administration costs and commercial arrangements). Only continue brolucizumab in people who maintain an adequate response to therapy. Criteria for stopping should include persistent deterioration in visual acuity and identification of anatomical changes in the retina that indicate inadequate response to therapy. 2. TA675: Vernakalant for NICE is unable to make a recommendation about the Not listed No cost impact to CCGs as appraisal terminated by the rapid conversion of use in the NHS of vernakalant for the rapid conversion NICE and insufficient evidence to approve use. -
Promising Therapeutic Targets for Treatment of Rheumatoid Arthritis
REVIEW published: 09 July 2021 doi: 10.3389/fimmu.2021.686155 Promising Therapeutic Targets for Treatment of Rheumatoid Arthritis † † Jie Huang 1 , Xuekun Fu 1 , Xinxin Chen 1, Zheng Li 1, Yuhong Huang 1 and Chao Liang 1,2* 1 Department of Biology, Southern University of Science and Technology, Shenzhen, China, 2 Institute of Integrated Bioinfomedicine and Translational Science (IBTS), School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, China Rheumatoid arthritis (RA) is a systemic poly-articular chronic autoimmune joint disease that mainly damages the hands and feet, which affects 0.5% to 1.0% of the population worldwide. With the sustained development of disease-modifying antirheumatic drugs (DMARDs), significant success has been achieved for preventing and relieving disease activity in RA patients. Unfortunately, some patients still show limited response to DMARDs, which puts forward new requirements for special targets and novel therapies. Understanding the pathogenetic roles of the various molecules in RA could facilitate discovery of potential therapeutic targets and approaches. In this review, both Edited by: existing and emerging targets, including the proteins, small molecular metabolites, and Trine N. Jorgensen, epigenetic regulators related to RA, are discussed, with a focus on the mechanisms that Case Western Reserve University, result in inflammation and the development of new drugs for blocking the various United States modulators in RA. Reviewed by: Åsa Andersson, Keywords: rheumatoid arthritis, targets, proteins, small molecular metabolites, epigenetic regulators Halmstad University, Sweden Abdurrahman Tufan, Gazi University, Turkey *Correspondence: INTRODUCTION Chao Liang [email protected] Rheumatoid arthritis (RA) is classified as a systemic poly-articular chronic autoimmune joint † disease that primarily affects hands and feet. -
Newer-Generation EGFR Inhibitors in Lung Cancer: How Are They Best Used?
cancers Review Newer-Generation EGFR Inhibitors in Lung Cancer: How Are They Best Used? Tri Le 1 and David E. Gerber 1,2,3,* 1 Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX 75390-8852, USA; [email protected] 2 Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, TX 75390-8852, USA 3 Division of Hematology-Oncology, Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, TX 75390-8852, USA * Correspondence: [email protected]; Tel.: +1-214-648-4180; Fax: +1-214-648-1955 Received: 15 January 2019; Accepted: 4 March 2019; Published: 15 March 2019 Abstract: The FLAURA trial established osimertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), as a viable first-line therapy in non-small cell lung cancer (NSCLC) with sensitizing EGFR mutations, namely exon 19 deletion and L858R. In this phase 3 randomized, controlled, double-blind trial of treatment-naïve patients with EGFR mutant NSCLC, osimertinib was compared to standard-of-care EGFR TKIs (i.e., erlotinib or gefinitib) in the first-line setting. Osimertinib demonstrated improvement in median progression-free survival (18.9 months vs. 10.2 months; hazard ratio 0.46; 95% CI, 0.37 to 0.57; p < 0.001) and a more favorable toxicity profile due to its lower affinity for wild-type EGFR. Furthermore, similar to later-generation anaplastic lymphoma kinase (ALK) inhibitors, osimertinib has improved efficacy against brain metastases. Despite this impressive effect, the optimal sequencing of osimertinib, whether in the first line or as subsequent therapy after the failure of earlier-generation EGFR TKIs, is not clear. -
ALK Tyrosine Kinase Inhibitors, 5.01.538
PHARMACY POLICY – 5.01.538 ALK Tyrosine Kinase Inhibitors Effective Date: June 1, 2021 RELATED MEDICAL POLICIES: Last Revised: May 20, 2021 None Replaces: N/A Select a hyperlink below to be directed to that section. POLICY CRITERIA | CODING | RELATED INFORMATION EVIDENCE REVIEW | REFERENCES | HISTORY ∞ Clicking this icon returns you to the hyperlinks menu above. Introduction The anaplastic lymphoma kinase (ALK) gene provides instructions for making a specific kind of protein called ALK receptor tyrosine kinase. This protein helps cells communicate. When this gene is damaged, cell growth can get stuck in the “on” position and cells grow uncontrollably. Changes to the ALK gene can lead to non-small-cell lung cancer. Tyrosine kinase inhibitors block specific enzymes, essentially working to turn the cell growth to the “off” position. ALK tyrosine kinase inhibitors specifically targets cancers caused by changes to the ALK gene. This policy describes when this specific form of chemotherapy may be considered medically necessary. Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered. Policy Coverage Criteria Drug Medical Necessity Alecensa® (alectinib) Alecensa® (alectinib) may be considered medically necessary for the treatment of adult patients with advanced or Drug Medical Necessity metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive. -
Jyseleca, INN-Filgotinib
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Jyseleca 100 mg film-coated tablets Jyseleca 200 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Jyseleca 100 mg film-coated tablets Each film-coated tablet contains filgotinib maleate equivalent to 100 mg of filgotinib. Excipient with known effect Each 100 mg film-coated tablet contains 76 mg of lactose (as monohydrate). Jyseleca 200 mg film-coated tablets Each film-coated tablet contains filgotinib maleate equivalent to 200 mg of filgotinib. Excipient with known effect Each 200 mg film-coated tablet contains 152 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Jyseleca 100 mg film-coated tablets Beige 12 × 7 mm, capsule-shaped, film-coated tablet debossed with “GSI” on one side and “100” on the other side. Jyseleca 200 mg film-coated tablets Beige 17 × 8 mm, capsule-shaped, film-coated tablet debossed with “GSI” on one side and “200” on the other side. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Jyseleca is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Jyseleca may be used as monotherapy or in combination with methotrexate (MTX). -
Sequential ALK Inhibitors Can Select for Lorlatinib-Resistant Compound ALK Mutations in ALK-Positive Lung Cancer
Published OnlineFirst April 12, 2018; DOI: 10.1158/2159-8290.CD-17-1256 RESEARCH ARTICLE Sequential ALK Inhibitors Can Select for Lorlatinib-Resistant Compound ALK Mutations in ALK-Positive Lung Cancer Satoshi Yoda1,2, Jessica J. Lin1,2, Michael S. Lawrence1,2,3, Benjamin J. Burke4, Luc Friboulet5, Adam Langenbucher1,2,3, Leila Dardaei1,2, Kylie Prutisto-Chang1, Ibiayi Dagogo-Jack1,2, Sergei Timofeevski4, Harper Hubbeling1,2, Justin F. Gainor1,2, Lorin A. Ferris1,2, Amanda K. Riley1, Krystina E. Kattermann1, Daria Timonina1, Rebecca S. Heist1,2, A. John Iafrate6, Cyril H. Benes1,2, Jochen K. Lennerz6, Mari Mino-Kenudson6, Jeffrey A. Engelman7, Ted W. Johnson4, Aaron N. Hata1,2, and Alice T. Shaw1,2 Downloaded from cancerdiscovery.aacrjournals.org on September 30, 2021. © 2018 American Association for Cancer Research. Published OnlineFirst April 12, 2018; DOI: 10.1158/2159-8290.CD-17-1256 ABSTRACT The cornerstone of treatment for advanced ALK-positive lung cancer is sequential therapy with increasingly potent and selective ALK inhibitors. The third-generation ALK inhibitor lorlatinib has demonstrated clinical activity in patients who failed previous ALK inhibi- tors. To define the spectrum ofALK mutations that confer lorlatinib resistance, we performed accel- erated mutagenesis screening of Ba/F3 cells expressing EML4–ALK. Under comparable conditions, N-ethyl-N-nitrosourea (ENU) mutagenesis generated numerous crizotinib-resistant but no lorlatinib- resistant clones harboring single ALK mutations. In similar screens with EML4–ALK containing single ALK resistance mutations, numerous lorlatinib-resistant clones emerged harboring compound ALK mutations. To determine the clinical relevance of these mutations, we analyzed repeat biopsies from lorlatinib-resistant patients. -
Study Protocol
~ GILEAU CLINICAL STUDY PROTOCOL Study Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-9876 in Subjects with Active Rheumatoid Althritis on Background Therapy with Methotrexate Sponsor: Gilead Sciences, Inc. 333 Lakeside Drive Foster City, CA 94404 INDNumber: IND 123903 EudraCT Number: 2016-001496-75 Clinical Trials.gov Identifier: TBD Indication: Rheumatoid Arthritis Protocol ID: GS-US-379-1582 Gilead Clinical Name: TomDoan Program Manager: Telephone: PPD Gilead Medical Name: Franziska Matzkies Monitor: Telephone: PPD Fax: PPD Mobile: PPD Protocol Version/Date: Original: 08 April 2016 Amendment 1: 27 Jlme 2016 CONFIDENTIALITY STATEMENT The infonnation contained in this document, pruticularly unpublished data, is the prope1ty or under control of Gilead Sciences, Inc., and is provided to you in confidence as an investigator, potential investigator, or consultant, for review by you, your staff, and an applicable Institutional Review Board or Independent Ethics Committee. The infmmation is only to be used by you in connection with authorized clinical studies of the investigational dmg described in the protocol. You will not disclose any of the infmmation to others without written authorization from Gilead Sciences, Inc., except to the extent necessa1y to obtain inf01med consent from those persons to whom the dmg may be administered. GS-9876 Protocol GS-US-379-1582 Gilead Sciences, Inc. Amendment 1 TABLE OF CONTENTS TABLE OF CONTENTS ..............................................................................................................................................2 -
CHMP Agenda of the 19-22 April 2021 Meeting
28 July 2021 EMA/CHMP/220334/2021 Corr.11 Human Medicines Division Committee for medicinal products for human use (CHMP) Agenda for the meeting on 19-22 April 2021 Chair: Harald Enzmann – Vice-Chair: Bruno Sepodes 19 April 2021, 09:00 – 19:30, virtual meeting/ room 1C 20 April 2021, 08:30 – 19:30, virtual meeting/ room 1C 21 April 2021, 08:30 – 19:30, virtual meeting/ room 1D 22 April 2021, 08:30 – 19:00, virtual meeting/ room 1C 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. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006). 1 Correction in section 8.1.1 Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2021.