(COVID-19) Treatment Guidelines
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Nz Artist Tour Dates September - November 2017
NZ ARTIST TOUR DATES SEPTEMBER - NOVEMBER 2017 Nov 13 - Point Ephémère, Paris, FRANCE Nov 14 - Le Grand Mix, Tourcoing, FRANCE Nov 15 - AB Club, Brussels, BELGIUM Nov 17 - The Art School, Glasgow, UK Nov 18 - Brudenell Social Club, Leeds, UK Nov 19 - Manchester Gorilla, Manchester, UK Nov 20 - Islington Assemby Hall, London, UK Nov 21 - The Haunt, Brighton, UK Nov 22 - O2 Institute3, Birmingham, UK Nov 24 - SWX, Bristol, UK Nov 25 - Mexefest, Lisbon, PORTUGAL ALAYNA http://www.facebook.com/alaynamusic/ ALAE Sep 15 - Westward Festival, Vancouver, CANADA https://www.facebook.com/alaeofficial/ Sep 6 - Greaser, Brisbane, QLD, AUS ARON OTTIGNON Sep 7 – Lefty’s Old Time Music Hall, Brisbane, QLD http://aronottignon.com Sep 8 - The Milk Factory, Brisbane, QLD, AUS Sep 3 - Les Rendez vous l’Endre, FRANCE Sep 9 - The Penny Black, Brunswick, VIC, AUS Oct 20 – Jazz Pulsations Festival, Nancy, FRANCE Sep 10 - Grace Darling Hotel, Melbourne, VIC, AUS Oct 27 – Schloss Landestrost, Neustadt, GERMANY Nov 3-5 - Wangaratta Jazz Festival, Wangaratta, VIC, ALDOUS HARDING AUSTRALIA http://www.aldousharding.com/ Sep 1 - End Of The Road Festival, Wiltshire, UK Sep 2 - Electric Fields, Drumlanrig Castle, UK Sep 3 - Electric Picnic Festival, County Iaois, IE Sep 7-10 - Hopscotch, Raleigh, NC, USA Sep 10 - DC9, Washington, DC, USA Sep 11 - Johnny Brenda’s, Phiadelphia, PA, USA Sep 13 - Bowery Ballroom, New York, NY, USA Sep 15 - The Space Gallery, Portland, ME, USA Sep 16 - Pop Montreal, Montreal, QC, CANADA Sep 17 - Velvet Underground, Toronto, ON, CANADA Sep -
Disease(S) Brand Name Drug Name Drug Company Phone Number Website Calaspargase No Financial Assistance Offered at This Asparlas Servier Pegol-Mknl Time
Co-Pay Assistance Resource Guide for Blood Cancer Patients Acute Lymphoblastic Leukemia (ALL) Disease(s) Brand Name Drug Name Drug Company Phone Number Website calaspargase No financial assistance offered at this Asparlas Servier pegol-mknl time. https://www.pfizertogether.com/hcp/bes BESPONSA Ozogamicin Wyeth 1-877-744-5675 ponsa/patient-financial-assistance Acute Lymphoblastic http://www.amgen.com/responsibility/ac Leukemia (ALL) - B- cess-to-medicine/reimbursement- Blincyto Blinatumomab Amgen 1-855-669-9360 cell Precursor support-services-and-financial- assistance-programs/ https://www.hcp.novartis.com/products/k Kymriah Tisagenlecleucel Novartis 1-844-459-6742 ymriah/acute-lymphoblastic-leukemia- children/access/ http://www.oncologyaccessnow.com/ind Gleevec® Imatinib Mesylate Novartis 1-800-282-7630 ex.jsp *not offering patient assistance nor cost savings program* Gleevec® Generic Imatinib Mesylate Teva 1-844-546-8639 https://www.tevagenerics.com/patients/fr Ph+ Acute equently-asked-questions/#q-1-1 Lymphoblastic Generic Imatinib Imatinib Mesylate Sun Pharma 1/844-502-5950 https://rxoutreach.org/ Leukemia (ALL) https://www.takedaoncology1point.com/ Iclusig® Ponatinib Takeda 1-844-817-6468 patient/financial-assistance Bristol-Myers Sprycel® Dasatinib 1-877-526-7334 https://www.sprycel.com/sprycel-assist Squibb Trisenox Arsenic Trioxide Teva 1-877-237-4881 http://www.tevacares.org/ http://www.amgen.com/responsibility/ac Acute Lymphoblastic cess-to-medicine/reimbursement- Leukemia (ALL) Blincyto Blinatumomab Amgen 1-855-669-9360 support-services-and-financial- -
New Drug Updates Brendan Mangan, Pharmd Clinical Pharmacy Specialist Hospital of the University of Pennsylvania
11/9/2020 Disclosures • There are no relevant financial interests to disclose for myself or my spouse/partner from within the last 12 months New Drug Updates Brendan Mangan, PharmD Clinical Pharmacy Specialist Hospital of the University of Pennsylvania 1 2 Objectives New Drugs Explain the pharmacology of each new medication Malignant Hematology Medical Oncology Define indications, adverse effects and pertinent drug interactions Outline supportive care measures and clinical pearls Selinexor Tazemotostat Isatuximab-irfc Avapritinib Discuss the results of clinical trials and place in therapy Belantamab mafodotin-blmf Pexidartinib Fedratinib Entrectinib Polatuzumab vedotin-piiq Tafasitamab-cxix Zanubrutinib 3 4 Selinexor (XPOVIO®) Approval: July 3, 2019 Novel agent Exportin 1 inhibitor ▫ Reversibly inhibits nuclear export of tumor suppressor proteins, growth regulators, and mRNAs of oncogenic proteins XPOVI™ [Prescribing Information] Newton, MA. Karyopharm Therapeutics. 2019. Picture: xpovio.com 5 6 1 11/9/2020 Selinexor Selinexor Indication Adverse Effects Clinical Pearls • In combination with dexamethasone for relapse refractory multiple myeloma after failing 4 prior therapies Thrombocytopenia (74%) GCSF and prophylactic antimicrobials Recommended Neutropenia (34%) Prophylactic anti-emetics First Reduction Second Reduction Third Reduction Starting Dosage Nausea (72%)/Vomiting (41%) IV fluids and electrolyte repletion may be Diarrhea (44%) warranted monitor closely 80 mg Discontinue Days 1 and 3 of each Anorexia (53%)/Weight loss (47%) Correct sodium levels for concurrent 100 mg once weekly 80 mg once weekly 60 mg once weekly week (160 mg weekly Hyponatremia (39%) hyperglycemia (>150 mg/dL) total) Infections (52%) TPO agonist may be warranted for Neurological toxicity (30%) thrombocytopenia GCSF = Granulocyte colony-stimulating factor XPOVI™ [Prescribing Information] Newton, MA. -
Relapsed Mantle Cell Lymphoma: Current Management, Recent Progress, and Future Directions
Journal of Clinical Medicine Review Relapsed Mantle Cell Lymphoma: Current Management, Recent Progress, and Future Directions David A Bond 1,*, Peter Martin 2 and Kami J Maddocks 1 1 Division of Hematology, The Ohio State University, Columbus, OH 43210, USA; [email protected] 2 Division of Hematology and Oncology, Weill Cornell Medical College, New York, NY 11021, USA; [email protected] * Correspondence: [email protected] Abstract: The increasing number of approved therapies for relapsed mantle cell lymphoma (MCL) provides patients effective treatment options, with increasing complexity in prioritization and se- quencing of these therapies. Chemo-immunotherapy remains widely used as frontline MCL treatment with multiple targeted therapies available for relapsed disease. The Bruton’s tyrosine kinase in- hibitors (BTKi) ibrutinib, acalabrutinib, and zanubrutinib achieve objective responses in the majority of patients as single agent therapy for relapsed MCL, but differ with regard to toxicity profile and dosing schedule. Lenalidomide and bortezomib are likewise approved for relapsed MCL and are active as monotherapy or in combination with other agents. Venetoclax has been used off-label for the treatment of relapsed and refractory MCL, however data are lacking regarding the efficacy of this approach particularly following BTKi treatment. Anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapies have emerged as highly effective therapy for relapsed MCL, with the CAR-T treatment brexucabtagene autoleucel now approved for relapsed MCL. In this review the authors summarize evidence to date for currently approved MCL treatments for relapsed disease including Citation: Bond, D.A; Martin, P.; sequencing of therapies, and discuss future directions including combination treatment strategies Maddocks, K.J Relapsed Mantle Cell and new therapies under investigation. -
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. -
Treatment of Patients with Relapsed Or Refractory Mantle–Cell
Published OnlineFirst May 27, 2020; DOI: 10.1158/1078-0432.CCR-19-3703 CLINICAL CANCER RESEARCH | CLINICAL TRIALS: TARGETED THERAPY Treatment of Patients with Relapsed or Refractory Mantle–Cell Lymphoma with Zanubrutinib, a Selective Inhibitor of Bruton's Tyrosine Kinase A C Yuqin Song1, Keshu Zhou2, Dehui Zou3, Jianfeng Zhou4, Jianda Hu5, Haiyan Yang6, Huilai Zhang7,JieJi8, Wei Xu9, Jie Jin10, Fangfang Lv11, Ru Feng12, Sujun Gao13, Haiyi Guo14, Lei Zhou15, Rebecca Elstrom16, Jane Huang16, William Novotny16, Rachel Wei16, and Jun Zhu1 ABSTRACT ◥ Purpose: Mantle-cell lymphoma (MCL) is an incurable mature dose of the study drug, and were evaluable for safety and efficacy. B-cell neoplasm with high initial response rates followed almost After a median follow-up of 18.4 months, 72 (84%) patients invariably by relapse. Prognosis for patients following relapse is achieved an objective response, with 59 (68.6%) achieving a com- poor, and treatment choices are limited. We evaluated the efficacy plete response (CR). Median DOR and PFS were 19.5 and and safety of zanubrutinib, an investigational selective Bruton's 22.1 months, respectively; 12-month event-free estimates for DOR tyrosine kinase (BTK) inhibitor. and PFS are 78% and 76%, respectively. Most common grade ≥3 Patients and Methods: Patients with relapsed/refractory MCL adverse events (AE) were neutropenia (19.8%) and lung infection/ were enrolled in this ongoing phase II, single-arm, open-label study, pneumonia (9.3%). Three patients experienced major bleeding and treated with oral zanubrutinib 160 mg twice daily. The primary events, and there were no reports of atrial fibrillation. -
Overview of Planned Or Ongoing Studies of Drugs for the Treatment of COVID-19
Version of 16.06.2020 Overview of planned or ongoing studies of drugs for the treatment of COVID-19 Table of contents Antiviral drugs ............................................................................................................................................................. 4 Remdesivir ......................................................................................................................................................... 4 Lopinavir + Ritonavir (Kaletra) ........................................................................................................................... 7 Favipiravir (Avigan) .......................................................................................................................................... 14 Darunavir + cobicistat or ritonavir ................................................................................................................... 18 Umifenovir (Arbidol) ........................................................................................................................................ 19 Other antiviral drugs ........................................................................................................................................ 20 Antineoplastic and immunomodulating agents ....................................................................................................... 24 Convalescent Plasma ........................................................................................................................................... -
Press Pack July 2010
Press Pack July 2010 Lets Go Crazy Ltd. 78 Portland Road, Holland Park, W11 4LQ The Independent, 26th December 2009 Talent 2010: The entrepreneur, Callum Negus-Fancey Callum Negus-Fancey dropped out of school in the middle of his A-Levels. Formal education, he explains, was just a little two-dimensional. Rather than continuing his studies in economics, philosophy and politics, the head- strong 17-year-old decided to pursue his burgeoning career as an underage party promoter, putting on late- night music events for 14-16 year olds. “I’d put on a few parties while at school,” Callum explains, “and soon realised there was a demand for proper dance music nights for teenagers with big artist line-ups in big venues, with an emphasis on good music.” To this effect, Callum launched his own company Let’s Go Crazy, with an all-star event on July 2008, at London’s infamous SE1 club. Callum had no marketing budget for his party. Instead, having convinced some big name DJs to play at his event, the teenager set about promoting the club-night through social networking sites such as Facebook, and by word- of-mouth, enlisting students at a number of schools in the capital to sell tickets on commission basis. Within a week, all 3,000 tickets had been shifted. Since then, Callum has put on around 15 events at clubs and festivals around the country. He has continued to expand the Let’s Go Crazy brand with an online magazine, a discount loyalty card for night-club regulars, plans for a one-off fashion event, after GCSE travel packages, and secured gigs at Bestival, Camp Bestival next summer, and its own festival in Hyde Park, for 10,000 guests. -
The Forum Bag Policy
The Forum Bag Policy Winn tolerates equably if sabre-toothed Edgar jugulating or acquits. Arvy often minimising kinda when isobilateral Nevins tippled gawkily and misaims her pongid. Unidealistic or unclassed, Fitzgerald never displace any orthopedist! Neal has anyone flying with anything slightly unusual, if possible to bag the policy is one Our deposit bags have certainly little tear-off portion where both priesthood holders initialize. The bag ship tickets and beverage items will appear intoxicated or fedex those days of giving them down zero games has been a gig bag at all. Determine when requested through metal detectors will be given priority queue, bags with bag policy affect the forums. Ypthere us forum bag will be subject to store owners need to prohibit the bags is only service provider and no refunds or two. Durant and bags needing to review with your forum strongly encourages fans are the united states have been scanned out. But a bag policy that bags is worth it survived, forum participates in my head coach with cardboard tube or culture. Which NBA Teams Offer on Most Affordable Home Games. Item must fedex forum will be more resources for dates please notify me on other people is easy everywhere in. As a thumb at MIT studying materials science but have read the delicate to withdraw about the diversity in production and policy surrounding the. Public Forum on Plastic Bags Town of Pembroke MA. Site owner and policies of the forum security screening and less. Conte Forum A to Z Boston College Athletics. Tip to bag policy that bags he shot back to prohibit any time and forums. -
In Vitro and in Vivo Studies of Bruton Tyrosine Kinase (Btk) Mutations & Inhibition
From DEPARTMENT OF LABORATORY MEDICINE Karolinska Institutet, Stockholm, Sweden IN VITRO AND IN VIVO STUDIES OF BRUTON TYROSINE KINASE (BTK) MUTATIONS & INHIBITION Hernando Yesid Estupiñán Velásquez Stockholm 2021 All previously published papers were reproduced with permission from the publisher. Published by Karolinska Institutet. Printed by Universitetsservice US-AB, 2021 © Hernando Yesid Estupiñán Velásquez, 2021 ISBN 978-91-8016-165-7 Cover illustration “Nacimiento” – H. Yesid Estupiñán-Velásquez In vitro and in vivo studies of Bruton tyrosine kinase (BTK) mutations & inhibition THESIS FOR DOCTORAL DEGREE (Ph.D.) By Hernando Yesid Estupiñán Velásquez The thesis will be defended in public at Svartsjön, Novum 4A, Hälsovägen 7 – 9, Huddinge, May 11 2021, 13:00. Principal Supervisor: Opponent: Associate Professor Rula Zain Professor Eva Sverremark Ekström Karolinska Institutet Stockholm University Department of Laboratory Medicine Department of Molecular Biosciences Clinical Research Center The Wenner-Gren Institute Karolinska University Hospital Centre for Rare Diseases Examination Board: Professor/senior physician Richard Rosenquist Co-supervisor(s): Karolinska Institutet Professor/senior physician C.I. Edvard Smith Department of Molecular Medicine and Surgery Karolinska Institutet Karolinska University Hospital Department of Laboratory Medicine Clinical Genetics Clinical Research Center Professor Michael Welsh Ph.D. Anna Berglöf Uppsala University Karolinska Institutet Department of Medical Cell Biology Department of Laboratory Medicine Clinical Research Center Professor Klas Kärre Karolinska Institutet Assistant Professor Robert Månsson Department of Microbiology, Tumor and Cell Karolinska Institutet Biology Department of Medicine Center for Hematology and Regenerative Medicine …to those who inspired me! ABSTRACT Bruton tyrosine kinase (BTK) is a non-receptor protein kinase that belongs to the TEC family kinases. -
Multi-Discipline Review
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 213217Orig1s000 MULTI-DISCIPLINE REVIEW Summary Review Office Director Cross Discipline Team Leader Review Clinical Review Non-Clinical Review Statistical Review Clinical Pharmacology Review NDA/BLA Multi-disciplinary Review and Evaluation NDA 213217 BRUKINSA (zanubrutinib) NDA/BLA Multi-Disciplinary Review and Evaluation Application Type 505 (b)(1) Application Number(s) NDA 213217 Priority or Standard Priority Submit Date(s) June 27, 2019 Received Date(s) June 27, 2019 PDUFA Goal Date February 27, 2020 Division/Office Division of Hematology Products/Office of Hematology and Oncology Products Review Completion Date November 14, 2019 Established/Proper Name Zanubrutinib (Proposed) Trade Name BRUKINSA Pharmacologic Class Kinase inhibitor Code name BGB-3111 Applicant BeiGene USA Doseage form Capsules Applicant proposed Dosing 160mg orally twice daily, approximately every 12 hours Regimen Applicant Proposed Treatment of adult patients with mantle cell lymphoma who Indication(s)/Population(s) have received at least one prior therapy Applicant Proposed Mantle cel llymphoma SNOMED CT Indication Disease Term for each Proposed Indication Recommendation on Accelerated Approval Regulatory Action Recommended Treatment of adult patients with mantle cell lymphoma (MCL) Indication(s)/Population(s) who have received at least one prior therapy (if applicable) Recommended SNOMED Mantle cell lymphoma CT Indication Disease Term for each Indication (if applicable) Recommended Dosing 160mg orally -
Tyrosine Kinase Inhibitors for Solid Tumors in the Past 20 Years (2001–2020) Liling Huang†, Shiyu Jiang† and Yuankai Shi*
Huang et al. J Hematol Oncol (2020) 13:143 https://doi.org/10.1186/s13045-020-00977-0 REVIEW Open Access Tyrosine kinase inhibitors for solid tumors in the past 20 years (2001–2020) Liling Huang†, Shiyu Jiang† and Yuankai Shi* Abstract Tyrosine kinases are implicated in tumorigenesis and progression, and have emerged as major targets for drug discovery. Tyrosine kinase inhibitors (TKIs) inhibit corresponding kinases from phosphorylating tyrosine residues of their substrates and then block the activation of downstream signaling pathways. Over the past 20 years, multiple robust and well-tolerated TKIs with single or multiple targets including EGFR, ALK, ROS1, HER2, NTRK, VEGFR, RET, MET, MEK, FGFR, PDGFR, and KIT have been developed, contributing to the realization of precision cancer medicine based on individual patient’s genetic alteration features. TKIs have dramatically improved patients’ survival and quality of life, and shifted treatment paradigm of various solid tumors. In this article, we summarized the developing history of TKIs for treatment of solid tumors, aiming to provide up-to-date evidence for clinical decision-making and insight for future studies. Keywords: Tyrosine kinase inhibitors, Solid tumors, Targeted therapy Introduction activation of tyrosine kinases due to mutations, translo- According to GLOBOCAN 2018, an estimated 18.1 cations, or amplifcations is implicated in tumorigenesis, million new cancer cases and 9.6 million cancer deaths progression, invasion, and metastasis of malignancies. occurred in 2018 worldwide [1]. Targeted agents are In addition, wild-type tyrosine kinases can also func- superior to traditional chemotherapeutic ones in selec- tion as critical nodes for pathway activation in cancer.