DOCSLIB.ORG

Disease(S) Brand Name Drug Name Drug Company Phone Number Website Calaspargase No Financial Assistance Offered at This Asparlas Servier Pegol-Mknl Time

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
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- (Ph negative) assistance-programs/ Acute Myeloid Leukemia (AML) Disease(s) Brand Name Drug Name Drug Company Phone number Website https://www.bmsaccesssupport.bmscust Onureg Azacitidine BMS 1-800-861-0048 omerconnect.com/patient Good Days http://www.needymeds.org/drug_list.taf? Dacogen Decitabine 1-877-968-7233 Program _function=name&name=Dacogen http://www.pfizerrxpathways.com/?step= Idamycin Idarubicin Pfizer 1-866-706-2400 1&step=1&step=1 https://www.celgenepatientsupport.com/ IDHIFA Enasidenib Celgene 1-800-931-8691 enrollment/ Acute Myeloid Mylotarg Ozogamicin Pfizer 1-844-989-7284 www.pfizerrxpathways.com Leukemia Nivestym (a biosimilar to filgrastim-aafi Pfizer 1-844-989-7284 www.pfizerrxpathways.com Neupogen) https://www.copay.novartisoncology.co RYDAPT Midostaurin Novartis 1-877-557-7756 m Abbvie/Genentec https://www.genentech- Venclexta Venetoclax 1-855-692-6729 h access.com/hcp/brands/venclexta.html Page 1 of 13 Acute Myeloid https://www.pfizeroncologytogether.com Daurismo Glasdegib Pfizer 877-744-5675 Leukemia (AML) 75 yrs. / and older or Abbvie/Genentec https://www.genentech- Comorbidities (no Venclexta Venetoclax 1-855-692-6729 h access.com/hcp/brands/venclexta.html chemo option) Acute Myeloid Leukemia (AML) Mylotarg Ozogamicin Pfizer 1-844-989-7284 www.pfizerrxpathways.com CD33-Positive AML Tx for blastic plasmacytoid dendritic cell neoplasm (BPDCN) Stemline Elzonris tagraxofusp-erzs 1-833-478-3654 https://www.stemlinearc.com/ in adult and pediatric Therapeutics patients two years and older Jazz (t-AML) or AML with Daunorubicin - Pharmaceutical Myelodysplasia-related VYXEOS 1-855-589-9367 www.vyxeos.com Cytarabine Jump Start changes (AML-MRC) Program Acute Myeloid Agios Leukemia (AML) with a https://www.needymeds.org/papforms/m Tibsovo ivosidenib Pharmaceuticals, 1-844-409-1141 susceptible IDH1 yaefe2609.pdf Inc. mutation Relapsed or refractory Acute Myeloid Leukemia with an https://www.celgenepatientsupport.com/ IDHIFA Enasidenib Celgene 1-800-931-8691 isocitrate enrollment/ dehydrogenase-2 (IDH2) mutation https://www.copay.novartisoncology.co Relapsed or refractory RYDAPT Midostaurin Novartis 1-877-557-7756 m Acute Myeloid https://www.astellaspharmasupportsoluti Leukemia (AML) with a Astellas Pharma XOSPATA gilteritinib 1-844-632-9272 ons.com/products/xospata/patient_enroll FLT3 mutation US ment_process.aspx Newly-diagnosed therapy-related acute myelod leukemia (t- AML) or AML with Daunorubicin - Jazz myelodysplasia-related Vyxeos 1-855-589-9367 www.vyxeos.com Cytarabine Pharmaceuticals changes (AML-MRC) including pediatric patients 1 year and older. Acute Promyelocytic Leukemia Disease(s) Brand Name Drug Name Drug Company Phone number Website Jazz Acute Promyelocytic Daunorubicin - Pharmaceutical VYXEOS 1-855-589-9367 www.vyxeos.com Leukemia Cytarabine Jump Start Program Acute Graft Versus Host Disease (GvHD) Disease(s) Brand Name Drug Name Drug Company Phone number Website Steroid-refractory acute graft-versus-host https://www.incytecares.com/jakafi- disease in adult and Jakafi® Ruxolitinib Incyte 1-855-452-5234 copay-assistance.aspx pediactric patients 12 years and older Chronic Graft Versus Host Disease (cGVHD) Disease(s) Brand Name Drug Name Drug Company Phone number Website Page 2 of 13 Chronic Graft Versus Host Disease (cGVHD) Pharmacyclics/ https://www.imbruvica.com/patient- after failure of one or ImbruvicaTM Ibrutinib 1-877-877-3536 Janssen support/access-support more lines of systemic therapy Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Disease(s) Brand Name Drug Name Drug Company Phone number Website http://www.oncologyaccessnow.com/ind Arzerra Ofatumumab Novartis 1-800-282-7630 ex.jsp http://www.verastem.com/wp- COPIKTRA duvelisib Verastem 1-833-570-2273 content/uploads/2018/08/verastem- cares-form.pdf Chronic Lymphocytic Pharmacuclics/Ja https://www.imbruvica.com/patient- Leukemia (CLL)/Small ImbruvicaTM Ibrutinib 1-877-877-3536 nssen Biotech support/access-support Lymphocytic Lymphoma (SLL) https://www.genentech- Rituximab and Rituxan Hycela Genentech 1-888-249-4918 access.com/hcp/brands/rituxanhycela/fi Hyaluronidase nd-patient-assistance.html Abbvie/Genentec https://www.genentech- Venclexta Venetoclax 1-855-692-6729 h access.com/hcp/brands/venclexta.html Chronic Lymphocytic Leukemia (CLL) Disease(s) Brand Name Drug Name Drug Company Phone number Website Chronic Lymphocytic http://www.oncologyaccessnow.com/ind Arzerra Ofatumumab Novartis 1-800-282-7630 Leukemia (CLL) ex.jsp Page 3 of 13 Bendamustine Bendeka Teva 1-888-587-3263 http://bendeka.com/Support/assistance Hydrochloride http://www.genentech- Gazyva™ Obinutuzumab Genentech 1-888-249-4918 access.com/gazyva/patients Pharmacyclics/ https://www.imbruvica.com/patient- ImbruvicaTM Ibrutinib 1-877-877-3536 Janssen support/access-support http://www.genentech- Rituxan® Rituximab Genentech 1-888-249-4918 access.com/rituxan-nhl-cll/patients https://www.genentech- Rituximab and Rituxan Hycela Genentech 1-888-249-4918 access.com/hcp/brands/rituxanhycela/fi Chronic Lymphocytic Hyaluronidase nd-patient-assistance.html Leukemia (CLL) Treanda Bendamustine Teva 1-877-237-4881 http://www.tevacares.org/ Abbvie/Genentec https://www.genentech- Venclexta Venetoclax 1-855-692-6729 h access.com/hcp/brands/venclexta.html https://www.calquence.com/patient/supp AstraZeneca Calquence acalabrutinib 1-844-275-2360 ort-for-patients/commercial- Pharmaceuticals insurance.html 1-844-6ACCESS http://www.zydeligaccessconnect.com/h Zydelig® Idelalisib Gilead (1-844-622-2377) cp http://www.verastem.com/wp- COPIKTRA duvelisib Verastem 1-833-570-2273 content/uploads/2018/08/verastem- Chronic Lymphocytic cares-form.pdf Leukemia (CLL) with 17p deletion Abbvie/Genentec https://www.genentech- Venclexta Venetoclax 1-855-692-6729 h access.com/hcp/brands/venclexta.html Previously untreated Abbvie/Genentec https://www.genentech- chronic lymphocytic Venclexta Venetoclax 1-855-692-6729 h access.com/hcp/brands/venclexta.html leukemia (CLL) Chronic Myeloid Leukemia (CML) Disease(s) Brand Name Drug Name Drug Company Phone number Website Chronic Myeloid 1-855-4-BOSULIF Bosulif® Bosutinib Pfizer https://www.bosulif.com/bosulif-steps Leukemia (CML) 1-855-426-7854 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 equently-asked-questions/#q-1-1 Chronic Myeloid Gleevec® Generic Imatinib Mesylate Sun Pharma 1-844-502-5950 https://rxoutreach.org/ Leukemia (CML) https://www.takedaoncology1point.com/ Iclusig® Ponatinib Takeda 1-844-817-6468 patient/financial-assistance Synribo Omacetaxine Teva 1-877-237-4881 http://www.tevacares.org/ Bristol-Myers Sprycel® Dasatinib 1-877-526-7334 https://www.sprycel.com/sprycel-assist Squibb Tasigna® Nilotinib Novartis 1-866-972-5244 www.CoPay.NovartisOncology.com Newly-diagnosed 1-855-4-BOSULIF chronic phase (CP) Bosulif® Bosutinib Pfizer https://www.bosulif.com/bosulif-steps 1-855-426-7854 (Ph+)(CML) Chronic phase (CP) Bristol-Myers Sprycel® Dasatinib 1-877-526-7334 https://www.sprycel.com/sprycel-assist (Ph+)(CML) Squibb PH+ CML chronic phase/intolerant prior Tasigna® Nilotinib Novartis 1-866-972-5244 www.CoPay.NovartisOncology.com to TKI Page 4 of 13 Adult patients with chronic phase chronic myeloid leukemia (CP- https://www.takedaoncology1point.com/ Iclusig® Ponatinib Takeda 1-844-817-6468 CML) with resistance or patient/financial-assistance intolerance to at least 2 prior kinase inhibitors Hairy Cell Leukemia Disease(s) Brand Name Drug Name Drug Company Phone number Website https://www.myaccess360.com/hcp/hcp- AstraZeneca Hairy Cell Leukemia LUMOXITI pasudotox-tdfk 1-844-275-2360 branded-lumoxiti/support- Pharmaceuticals services/affordability-support.html Hodgkin lymphoma Disease(s) Brand Name Drug Name Drug Company Phone number Website https://www.merckaccessprogram- KEYTRUDA
Load more

Recommended publications
  • 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.
    [Show full text]
  • 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.
    [Show full text]
  • 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.
    [Show full text]
  • 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.
    [Show full text]
  • 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 ...........................................................................................................................................
    [Show full text]
  • 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.
    [Show full text]
  • (COVID-19) Treatment Guidelines
    COVID-19 Treatment Guidelines Coronavirus Disease 2019 (COVID-19) Treatment Guidelines Credit NIAID-RML How to Cite the COVID-19 Treatment Guidelines: COVID-19 Treatment Guidelines Panel. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. Available at https://www.covid19treatmentguidelines.nih.gov/. Accessed [insert date]. The COVID-19 Treatment Guidelines Panel regularly updates the recommendations in these guidelines as new information on the management of COVID-19 becomes available. The most recent version of the guidelines can be found on the COVID-19 Treatment Guidelines website (https://www.covid19treatmentguidelines.nih.gov/). Table of Contents What’s New in the Guidelines .................................................................................................. 5 The COVID-19 Treatment Guidelines Panel’s Statement on the Updated Emergency Use Authorization of the Anti-SARS-CoV-2 Monoclonal Antibody Combination Casirivimab Plus Imdevimab for the Treatment of COVID-19 ................................................ 9 The COVID-19 Treatment Guidelines Panel’s Statement on the Emergency Use Authorizations of Anti-SARS-CoV-2 Monoclonal Antibodies for the Treatment of COVID-19 ................................................................................................................................ 11 Introduction ............................................................................................................................ 16 Overview of COVID-19 ..........................................................................................................
    [Show full text]
  • 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
    [Show full text]
  • 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.
    [Show full text]
  • Unitedhealthcare Cancer Therapy Pathways Program Regimens
    UnitedHealthcare Cancer Therapy Pathways Program Overview 2 Breast Cancer 3 Pancreatic Cancer 15 Melanoma 19 Colon/Rectal Cancer 23 Hepatobiliary Cancers 30 Lung Cancer, Small Cell 35 Lung Cancer, Non-Small Cell 40 Ovarian, Fallopian and Primary Peritoneal Cancer 56 Head and Neck Cancer 67 Multiple Myeloma 74 Lymphoma, Diffuse Large B-Cell 86 Lymphoma, Follicular 92 Lymphoma, Marginal Zone 97 Lymphoma, Mantle Cell 101 Change control 1 OVERVIEW Cancer Therapy Pathways Program With the rapid approval of new therapies, along with the rising cost of cancer care, pathways serve a critical role in the delivery of high-quality and high-value cancer treatments while reducing an unwarranted variation in care. The UnitedHealthcare Cancer Therapy Pathways Program aims to improve quality and value in cancer care by identifying anti-cancer regimens supported by evidence-based guidelines to help reduce total cost of care and improve outcomes. The program’s regimens are selected on the basis of clinical benefit (efficacy) and side-effect profile (toxicity). Among regimens with comparable efficacy and toxicity, additional consideration is given to the frequency of hospitalizations during therapy, duration of therapy, drug costs and total cost of care. Care decisions are between the physician and the patient The Cancer Therapy Pathways Program is not a substitute for the experience and judgment of a physician or other health care professional. Any clinician participating in the program must use independent medical judgment in the context of individual
    [Show full text]
  • Application for the Addition of Zanubrutinib on the WHO Model List of Essential Medicines
    2021 WHO Expert Committee on the Selection and Use of Essential Medicines Application for the addition of Zanubrutinib on the WHO Model List of Essential Medicines Submitted by BeiGene Co., Ltd. Version date: -November 24th 2020 Application for the addition of Zanubrutinib on the WHO Model List of Essential Medicines CONTENTS General items................................................................................................................................. 1 1. Summary statement of the proposal for inclusion, change or deletion ......................... 1 2. Relevant WHO technical department and focal point (if applicable) ........................... 1 3. Name of organization (s) consulted and/or supporting the application ......................... 1 4. International Nonproprietary Name and Anatomical Therapeutic Chemical code of the medicine 2 5. Dose forms (s) and strength (s) proposed for inclusion; including adult and age- appropriate pediatric dose forms/strengths (if appropriate) ........................................................... 2 6. Whether listing is requested as an individual medicine or as representative of a pharmacological class .................................................................................................................... 2 Treatment details, public health relevance and evidence appraisal and synthesis .................... 3 7. Treatment details (requirements for diagnosis, treatment and monitoring). ................. 3 8. Information supporting the public health relevance .....................................................
    [Show full text]
  • Drug-Induced Liver Injury (DILI): Current Status and Future Directions for Drug Development and the Post-Market Setting
    Drug-induced liver injury (DILI): Current status and future directions for drug development and the post-market setting A consensus by a CIOMS Working Group Council for International Organizations of Medical Sciences (CIOMS) Geneva 2020 Drug-induced liver injury (DILI): Current status and future directions for drug development and the post-market setting A consensus by a CIOMS Working Group Council for International Organizations of Medical Sciences (CIOMS) Geneva 2020 Copyright © 2020 by the Council for International Organizations of Medical Sciences (CIOMS) ISBN: 978-929036099-5 All rights reserved. CIOMS publications may be obtained directly from CIOMS through its publications e-module at https://cioms.ch/publications/. Further information can be obtained from CIOMS, P.O. Box 2100, CH-1211 Geneva 2, Switzerland, tel.: +41 22 791 6497, www.cioms.ch, e-mail: [email protected]. CIOMS publications are also available through the World Health Organization, WHO Press, 20 Avenue Appia, CH-1211 Geneva 27, Switzerland. This publication is freely available on the CIOMS website at: https://cioms.ch/publications/product/drug-induced-liver-injury/ Suggested citation: Drug-induced liver injury (DILI): Current status and future directions for drug development and the post-market setting. A consensus by a CIOMS Working Group. Geneva, Switzerland: Council for International Organizations of Medical Sciences (CIOMS), 2020. Note on style: This publication uses the World Health Organization’s WHO style guide, 2nd Edition, 2013 (WHO/KMS/WHP/13.1) wherever possible for spelling, punctuation, terminology and formatting. The WHO style guide combines British and American English conventions. Disclaimer: The authors alone are responsible for the views expressed in this publication, and those views do not necessarily represent the decisions, policies or views of their respective institutions or companies.
    [Show full text]